Medtronic 4193103 Technical Manual

Attain

Transvenous, bipolar, coronary sinus/cardiac vein pacing lead

OTW 4193

Technical manual

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective owners.

Attain, InSync, Medtronic

Required physician training 5

Device description 5

Contents of package 6 Accessory descriptions 6

Indications for use 6

Contraindications 6

Warnings and precautions 7

Potential adverse events 10

Clinical trials 11

Attain OTW Model 4193 left-heart lead study 11 Objectives 13 InSync Registry study 18

Directions for use 18

Placing the right ventricular lead 19 Preparing the delivery system 19 Accessing the subclavian vein 19 Inserting the guide catheter assembly 20 Obtaining venograms 20 Inserting the lead into the delivery system 20 Selecting the lead placement method 21 Placing the lead using a stylet 22 Preparing the guide wire 24 Placing the lead using a guide wire 26 Fixating the lead 28 Taking electrical measurements 28 Removing the guide catheter from the lead 29 Anchoring the lead 29 Connecting the lead 30 Placing the device and leads into the pocket 30 Post-implant evaluation 31

Detailed device description 32

Specifications (nominal) 32 Specifications drawing (nominal) 33

Medtronic warranty 34

Service 34

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Required physician training

In order to implant a Medtronic Attain OTW Model 4193 lead, physicians are required to:

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Thoroughly read this manual, and all associated device technical manuals.

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Provide a copy of the patient manual to the patient and discuss it with him or her and any other interested parties.

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Be trained on the following topics: – Indications for use – Device operation to ensure therapy delivery – Measuring and managing bi-ventricular thresholds – Assembly and use of LV lead implant tools – Placement of the LV lead – Patient management and system follow-up

Prior to implanting the system, Medtronic will certify that physicians received training.

Device description

The Medtronic Attain OTW Model 4193 steroid eluting, transvenous, unipolar, left ventricular, over the wire, cardiac vein pacing lead is designed for pacing and sensing via a cardiac vein.

The lead features a tapered annular platinum alloy electrode with a molded silicone rubber tip. This molded tip provides a fluid seal which allows guide wire passage and reduces blood ingress. The lead also features nickel alloy conductors, polyurethane insulation, and an

Unipolar (UNI) lead connector.

IS-1

The distal tip of the lead contains a maximum of 1.0 mg dexamethasone sodium phosphate. Upon exposure to body fluids, the steroid elutes from the lead tip. The steroid suppresses the inflammatory response that is believed to cause threshold rises typically associated with implanted pacing electrodes.

The Model 4193 lead can be positioned with the aid of a guide wire or with a stylet. If a stylet is used, use only the stylets packaged with the lead or in a stylet kit (downsized knob).

Note: To implant the Model 4193 in a cardiac vein, a compatible delivery system is required. A compatible delivery system includes a guide catheter and a hemostasis/introducer valve which allows passage through or removal from an IS-1 connector. Contact your Medtronic representative for further information regarding compatible delivery systems.

IS-1 UNI refers to an International Connector Standard (ISO 5841-3) whereby pulse generators and leads so designated are assured of a basic mechanical fit.

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Contents of package

The lead and accessories are supplied sterile. Each package contains the following items:

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One lead with stylet and anchoring sleeve

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Two guide wire insertion tools

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One guide wire clip

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One guide wire steering handle

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Extra stylets

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Product literature

Accessory descriptions

Stylet – A stylet provides additional stiffness and controlled flexibility

for maneuvering the lead into position. Each stylet knob is labeled with the stylet diameter and length.

Guide wire insertion tool – A guide wire insertion tool provides additional control when inserting a guide wire into the lead connector pin or the lead tip.

Anchoring sleeve – An anchoring sleeve secures the lead from moving and protects the lead insulation and conductors from damage caused by tight ligatures.

Guide wire steering handle – A guide wire steering handle is used only with guide wires 0.018” in diameter or less. The steering handle provides additional control and steerability of the guide wire.

Guide wire clip – A guide wire clip secures the excess guide wire and helps to protect and maintain the sterility of the guide wire.

Indications for use

The lead has application as part of a Medtronic biventricular pacing system.

Contraindications

Coronary vasculature – This lead is contraindicated for patients

with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.

Steroid use – Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg of dexamethasone sodium phosphate may be contraindicated.

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Warnings and precautions

For single use only – Do not resterilize and reimplant an

explanted lead.

Inspecting the sterile package – Carefully inspect the package prior to opening.

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If the seal or package is damaged, contact your local Medtronic representative.

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Do not use the product after its expiration date.

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The lead has been sterilized with ethylene oxide prior to shipment. If the integrity of the sterile package has been compromised prior to the expiration date, resterilize the lead using ethylene oxide.

Ethylene oxide resterilization – If the sterile package seal is broken, resterilize the device using a validated ethylene oxide process. Avoid resterilization techniques that could damage the lead.

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Refer to sterilizer instructions for operating instructions.

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Use an acceptable method for determining sterilizer effectiveness, such as biological indicators.

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Before resterilization, place the device in an ethylene oxide permeable package.

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Do not exceed temperatures of 55 °C (131 °F).

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Do not resterilize more than one time.

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Allow proper aeration of ethylene oxide residues prior to implant.

Steroid use – It has not been determined whether the warnings, precautions, or complications usually associated with injectable dexamethasone sodium phosphate apply to the use of this highly localized, controlled-release device. For a list of potential adverse effects, refer to the Physician’s Desk Reference.

Handling the steroid tip – Reducing the available amount of steroid may adversely affect low-threshold performance. Avoid reducing the amount of steroid available prior to lead implant.

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Do not allow the electrode surface to come in contact with surface contaminants.

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Do not wipe or immerse the electrode in fluid, except blood at the time of implant.

Handling the lead – Leads should be handled with care at all times.

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If a stylet is used for lead positioning, use only the stylets packaged with the lead or in a stylet kit (downsized knob). Other stylets may extend beyond the lead tip causing lead tip seal damage and/or patient injury.

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If the lead is damaged, do not implant it. Return the lead to your Medtronic representative.

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Protect the lead from materials that shed particles such as lint and dust. Lead insulators attract these particles.

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Handle the lead with sterile surgical gloves that have been rinsed in sterile water or a comparable substance.

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Do not severely bend, kink, or stretch the lead.

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Do not use surgical instruments to grasp the lead or connector pin.

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Do not immerse leads in mineral oil, silicone oil, or any other liquid, except blood at the time of implant.

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Use an anchoring sleeve with all leads. Ensure that the anchoring sleeve is positioned close to the lead’s connector pin, to prevent inadvertent passage of the sleeve into the vein. If wiping the lead is necessary prior to insertion, ensure that the anchoring sleeve remains in position.

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Do not force the guide catheter and/or leads if significant resistance is encountered. Use of guide catheters and/or leads may cause trauma to the heart.

Handling the guide wire – Use care when handling guide wires.

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Damage to a guide wire may prevent the guide wire from performing with accurate torque response and control and may cause vessel damage. For additional information about vessel damage and other potential adverse events, refer to the technical manual packaged with the appropriate product.

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If the distal end of the guide wire becomes severely kinked or twisted, it may be difficult to withdraw it back through the lead. Therefore, if there is an indication that the distal end of the guide wire has become damaged, or if there is a lot of resistance in guide wire passage, remove the lead and guide wire. Remove the guide wire from the lead and re-insert a new guide wire into the lead. Do not use excessive force to retract the guide wire from the lead.

Refer to the product literature packaged with the guide wire for additional information.

Handling the stylets – Use care when handling stylets.

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To minimize the likelihood of trauma to the vein and to maintain lead flexibility while advancing the lead through the vein keep the stylet withdrawn 1-2 cm or select a more flexible stylet.

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Do not use excessive force or surgical instruments when inserting a stylet.

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Avoid overbending, kinking, or blood contact on stylets.

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Use a new stylet when blood or other fluids accumulate on the stylet. Accumulated fluids may cause damage to the lead or difficulty in passing the stylet through the lead.

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Curving the distal end of the stylet prior to insertion into the lead will achieve a curvature at the distal end of the lead. Do not use a sharp object to impart a curve to the distal end of the stylet.

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Necessary hospital equipment – Keep external defibrillation equipment nearby for immediate use during the acute lead system testing, implant procedure, or whenever arrhythmias are possible or intentionally induced during post-implant testing. Back-up pacing should be readily available during implant. Use of the delivery system and/or leads may cause heart block.

Line-powered equipment – An implanted lead forms a direct current path to the myocardium. During lead implant and testing, use only battery-powered equipment or line-powered equipment specifically designed for this purpose, to protect against fibrillation that may be caused by alternating currents. Line-powered equipment used in the vicinity of the patient must be properly grounded. Lead connector pins must be insulated from any leakage currents that may arise from line-powered equipment.

Concurrent devices – Output pulses, especially from unipolar devices, may adversely affect device sensing capabilities. If a patient requires a separate stimulation device, either permanent or temporary, allow enough space between the leads of the separate systems to avoid interference in the sensing capabilities of the devices. Previously implanted pulse generators and implantable cardioverter defibrillators should generally be explanted.

Diathermy – People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs), and accompanying leads should not receive diathermy treatment. The interaction between the implant and diathermy can cause tissue damage, fibrillation, or damage to the device components, which could result in serious injury, loss of therapy, and/or the need to reprogram or replace the device.

Chronic repositioning or removal – Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development. Studies have not specifically evaluated the removal of left ventricular leads from the coronary venous vasculature. If a lead must be removed or repositioned, proceed with extreme caution. Return all removed leads to Medtronic.

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Verify lead length on the IS-1 label on the connector to choose an appropriate stylet kit (downsized knob) length when repositioning. Always choose a stylet kit (downsized knob) 3 cm shorter than the lead length. For example, choose a stylet kit (downsized knob) with stylets 75 cm long for a lead 78 cm long.

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Lead removal may result in avulsion of the endocardium, valve, or vein.

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Lead junctions may separate, leaving the lead tip and bare wire in the heart or vein.

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Chronic repositioning may adversely affect the low-threshold performance of a steroid eluting lead.

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Cap abandoned leads to avoid transmitting electrical signals.

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For leads that have been severed, seal the remaining lead end and suture the lead to adjacent tissue.

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If a lead is removed and repositioned, inspect it carefully for insulator or conductor coil damage prior to repositioning.

Potential adverse events

The potential adverse events (listed in alphabetical order) related to the use of transvenous leads include, but are not limited to, the following patient-related conditions:

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Cardiac dissection

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Cardiac perforation

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Cardiac tamponade

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Coronary sinus dissection

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Death

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Endocarditis

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Erosion through the skin

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Extracardiac muscle or

nerve stimulation

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Fibrillation or other arrhythmias

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Heart block

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Heart wall or vein wall rupture

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Hematoma/seroma

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Infection

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Myocardial irritability

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Myopotential sensing

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Pericardial effusion

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Pericardial rub

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Pneumothorax

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Rejection phenomena (local

tissue reaction, fibrotic tissue formation, pulse generator migration)

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Threshold elevation

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Thrombolytic and air

embolism

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Thrombosis

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Transvenous lead-related

thrombosis

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Valve damage (particularly

in fragile hearts)

Additional potential adverse events related to the lead and the programmed parameters include, but are not limited to, the following:

Potential adverse event

Lead dislodgment

Lead conductor fracture or insulation failure

Threshold elevation or exit block

Transient loss of capture or sensing may occur following surgery until lead stabilization takes place. If stabilization does not occur, lead dislodgment may be suspected.

Indicator of potential adverse event

Intermittent or continuous loss of capture or sensing

Intermittent or continuous oversensing

Intermittent or continuous loss of capture or sensing

Loss of capture

Corrective action to be considered

Reposition the lead.

Replace the lead.

Adjust the implantable device output. Replace or reposition the lead.

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Implant techniques that may damage the lead include, but are not limited to, the following:

Implant techniques that may damage the lead

Forcing the lead through the introducer/delivery system

Use of too medial of an approach with venous introducer resulting in clavicle & first rib binding

Puncturing the periosteum and/ or tendon when using subclavian introducer approach

Advancing the lead through the veins without the stylet or guide wire fully inserted

Inserting the proximal end of the guide wire through the lead tip seal without using the guide wire insertion tool

Advancing a stylet tip beyond the distal end of the lead tip seal

Possible effects on the lead

Electrode, conductor coil, and/or insulation damage

Conductor coil fracture, insulation damage

Tip distortion and/or insulation perforation

Lead tip seal damage Replace the lead.

Corrective action to be considered

Replace the lead.

Clinical trials

Attain OTW Model 4193 left-heart lead study

A prospective, multi-center trial conducted at 28 investigative sites in the United States evaluated the safety and effectiveness of the Medtronic InSync III cardiac resynchronization device and the Attain OTW Model 4193 left-heart lead in heart failure patients.

An investigational protocol pre-specified the performance criteria for both safety and effectiveness based on previous studies. For this study, patients who satisfied inclusion and exclusion criteria underwent a baseline evaluation to determine study eligibility and then underwent an implant attempt of the InSync III cardiac resynchronization system including an Attain OTW Model 4193 lead.

Key study inclusion criteria included patients with the following:

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Symptomatic congestive heart failure (NYHA classification III or IV).

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QRS duration of ≥ 130 ms.

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Left ventricular end diastolic diameter of ≥ 55 mm.

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Left ventricular ejection fraction ≤ 35%.

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A stable pharmacological medical regimen prior to implant of the cardiac resynchronization system. This included ACE-I or substitute for at least one month and a beta blocker for at least three months if tolerated.

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