Medtronic HARMONY-25 Instructions for Use

Harmony™

TPV 22 and TPV 25 Transcatheter Pulmonary Valves and Delivery Catheter System

Instructions for Use

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

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AOA™, Harmony™

Explanation of symbols on package labeling

MR Conditional

For US audiences only

Model

Size

Serial number

Consult instructions for use at this website

Catalog number

Lot number

Manufacturer

Do not resterilize

Do not reuse

Do not use if package is damaged

Sterilized using ethylene oxide

Sterile LC: Device has been sterilized using liquid chemical sterilants according to EN/ISO 14160

Use-by date

Quantity

Temperature limit

Nonpyrogenic

Keep dry

Do not freeze

Fragile, handle with care

Keep away from sunlight

Maximum guidewire diameter

Temperature limit maintained

Temperature limit exceeded

Date of manufacture

Manufactured in

Device

Model

TPV 22

HARMONY-22

TPV 25

HARMONY-25

Delivery catheter system

HARMONY-DCS

1.0 Device description

The Harmony TPV system consists of a self-expanding transcatheter pulmonary valve and a delivery catheter system.

Table 1: Model numbers

1.1 Transcatheter pulmonary valve (TPV)

The TPV consists of a porcine pericardial valve that is preserved in buffered 0.2% glutaraldehyde and sutured within a Nitinol frame that is sewn onto a polyester knit fabric. The inflow end of the TPV features an attachment suture loop on each crown to thread onto the delivery catheter system coil during loading. The TPV is treated with an alpha amino oleic acid antimineralization process (AOA), which has been shown to mitigate leaflet calcification in animal studies. A final sterilization step is performed using a 0.2% glutaraldehyde sterilant in which the TPV is preserved and packaged until used.

1.2 Patient anatomical criteria

Caution: The Harmony TPV bioprosthesis size must be appropriate to fit the patient’s anatomy measured using a perimeter base framework. Proper sizing of the device is the responsibility of the physician. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed in Chapter 5.

Caution: The Harmony device is not intended for patients previously treated with an RV-PA conduit or previously implanted bioprosthesis.

The Harmony TPV bioprosthesis is available in two sizes (TPV 22, model number HARMONY22 and TPV 25, model number HARMONY-25), and each is appropriate for a range of patient main pulmonary artery (PA) sizes (measured with ECG-gated CTA at the end of the diastolic phase, i.e. 90% time point in the cardiac cycle) as shown in Figure 1 and Figure 2 respectively. Please also note the following points:

• this device is intended to be implanted in a section of the main PA (between the RVOT and

main PA bifurcation) with proper distal, proximal and axial dimensions to ensure sufficient oversizing of the device with respect to the anatomy

• the perimeter values along the main PA should be compared to those of the device at all

possible implant locations or in all possible implant scenarios within the implant zone (i.e., within the main PA and between the RVOT and main PA bifurcation)

Harmony TPV22

Anatomical Size (perimeter-derived

Harmony TPV25

Anatomical Size (perimeter-derived

• the patient’s main PA should have cross-sectional perimeters described in Figure 1 or Figure

2 on the distal and proximal parts of the PA within the implant zone of the main PA

• the combined RVOT and overall PA length should be longer than or equal to the device

length

• The patient’s venous anatomy should accommodate an 8.33 mm (25Fr) delivery catheter

system

PA section

diameter)

(1) Outflow

Distal PA/Bifurcation

(2) Valve Housing >22 mm

(3) Inflow

Proximal PA/RVOT

Figure 1: TPV 22 (Nitinol frame profile) with dimensions and HARMONY-22 sizing matrix

PA section

22 mm - 28 mm

23 mm - 39 mm

diameter)

Figure 2: TPV 25 (Nitinol frame profile) with dimensions and HARMONY-25 sizing matrix

(1) Outflow

Distal PA/Bifurcation

(2) Valve Housing >25 mm

(3) Inflow

Proximal PA/RVOT

25 mm - 38 mm

32 mm - 48 mm

1.3 Delivery catheter system (DCS)

The delivery catheter system (DCS) has a braided outer shaft with a polytetrafluoroethylene (PTFE) lined capsule in which the TPV is housed. The DCS has a soft, tapered distal tip. The TPV is attached to the distal end of the DCS by the DCS coil and is protected by the capsule during delivery. The deployment of the self-expanding TPV is controlled by pulling back the outer shaft, allowing the TPV to open. Rotating the proximal handle on the proximal end of the DCS rotates the DCS coil and releases the TPV for final deployment.

The DCS has a nominal outside diameter of 8.33 mm (25 Fr) and a nominal effective length of 101 cm. The DCS is compatible with an 0.889 mm (0.035 in) intravascular guidewire.

1. Distal tip

2. Guidewire lumen

3. Delivery catheter system coil

4. Capsule

5. Outer shaft

Figure 3: Delivery catheter system

6. Hemostasis sleeve

7. Stopcock

8. Hemostasis valve body

9. Hemostasis actuator

10. Proximal handle

11. Proximal handle actuator

12. Guidewire luer

13. Loading funnel halves (packaged with delivery catheter system)

14. Capsule support tube (preloaded on the delivery catheter system)

2.0 Indications

The Harmony Transcatheter Pulmonary Valve (TPV) System is indicated for use in the management of pediatric and adult patients with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography and/or pulmonary regurgitant fraction ≥ 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement.

3.0 Contraindications

The following are contraindications for the use of this device:

• Active bacterial endocarditis or other active infections

• Known intolerance to Nitinol (titanium or nickel) or an anticoagulation/antiplatelet regimen

4.0 Warnings and precautions

Carefully read all warnings, precautions, and instructions for use for all components of the system before use. Failure to read and follow all instructions or failure to observe all stated warnings could cause serious injury or death to the patient.

4.1 Warnings

4.1.1 General

• Implantation of the Harmony TPV system should be performed only by physicians who have

received Harmony TPV system training.

• The transcatheter pulmonary valve (TPV) is to be used only in conjunction with the Harmony

delivery catheter system (DCS).

• This procedure should only be performed where emergency pulmonary valve surgery can be

performed promptly.

• Do not use any of the Harmony TPV system components if any of the following has

occurred:

• It has been dropped, damaged, or mishandled in any way

• The Use By date has elapsed

4.1.2 Transcatheter pulmonary valve (TPV)

• This device was designed for single use only. Do not reuse, reprocess, or resterilize the TPV.

Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.

• Do not resterilize the TPV by any method. Exposure of the device and container to

irradiation, steam, ethylene oxide, or other chemical sterilants renders the device unfit for use.

• The device is packaged with a temperature sensor. Do not freeze the device. Do not expose

the device to extreme temperatures. Do not use the device if the arrow on the sensor points to the symbol that indicates that the temperature limit has been exceeded.

• Do not use the device if any of the following have occurred:

• The tamper-evident seal is broken.

• The serial number tag does not match the container label.

• The arrow on the sensor points to the symbol that indicates that the temperature limit

has been exceeded.

• The device is not completely covered by the storage solution.

• Do not contact any of the Harmony TPV system components with cotton or cotton swabs.

• Do not expose any of the Harmony TPV system components to organic solvents, such as

alcohol.

• Do not introduce air into the catheter.

• Do not expose the device to solutions other than the storage and rinse solutions.

• Do not add or apply antibiotics to the device, the storage solution, or the rinse solution.

• Do not allow the device to dry. Maintain tissue moisture with irrigation or immersion.

• Do not attempt to repair a damaged device.

• Do not handle the valve leaflet tissue or use forceps to manipulate the valve leaflet tissue.

• Do not attempt to recapture the device once deployment has begun.

• Do not attempt to retrieve the TPV if any one of the outflow TPV struts is protruding from

the capsule. If any one of the outflow TPV struts has deployed from the capsule, the TPV must be released from the catheter before the catheter can be withdrawn.

• Do not attempt post-implant balloon dilatation (PID) of the TPV during the procedure, which

may cause damage to or failure of the TPV leading to injury to the patient resulting in reintervention.

4.1.3 Delivery catheter system (DCS)

• This device was designed for single use only. Do not reuse, reprocess, or resterilize the DCS.

• Do not reuse or resterilize the DCS.

• If resistance is met, do not advance the guidewire, DCS, or any other component without

first determining the cause and taking remedial action.

• Do not remove the guidewire from the DCS at any time during the procedure.

4.2 Precautions

4.2.1 General

• Clinical long-term durability has not been established for the Harmony TPV. Evaluate the

TPV performance as needed during patient follow-up.

• The safety and effectiveness of Harmony TPV implantation in patients with pre-existing

prosthetic heart valve or prosthetic ring in any position has not been demonstrated.

• The Harmony TPV system has not been studied in female patients of child-bearing potential

with positive pregnancy.

4.2.2 Before Use

• Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid

prolonged or repeated exposure to the chemical vapor. Use only with adequate ventilation. If skin contact occurs, immediately flush the affected area with water (for a minimum of 15 minutes) and seek medical attention immediately.

• The TPV and the glutaraldehyde storage solution are sterile. The outside of the TPV

container is nonsterile and must not be placed in the sterile field.

• The TPV and DCS should be used only in a sterile catheterization laboratory (cath lab)

environment. Ensure that sterile technique is used at all times.

• Strictly follow the TPV rinsing procedure.

• For TPV 25: Ensure that all green sutures have been removed from the attachment suture

loops on the TPV before loading onto the DCS.

• Prevent contamination of the TPV, its storage solution, and the DCS with glove powder.

• Verify the orientation of the TPV before loading it onto the DCS. The inflow end of the TPV

with attachment suture loops must be loaded first.

• Do not place excessive pressure on the TPV during loading.

• Inspect the sealed DCS packaging before opening. If the seal is broken or the packaging has

been damaged, sterility cannot be assured.

• Proper functioning of the DCS depends on its integrity. Use caution when handling the DCS.

Damage may result from kinking, stretching, or forceful wiping of the DCS.

• This DCS is not recommended to be used for pressure measurement or delivery of fluids.

• Carefully flush the DCS and maintain tight DCS connections to avoid the introduction of air

bubbles.

4.2.3 During Use

• The TPV segment is rigid and may make navigation through vessels difficult.

• Do not advance any portion of the DCS under resistance. Identify the cause of resistance

using fluoroscopy and take appropriate action to remedy the problem before continuing to advance the DCS.

• Careful management of the guidewire is recommended to avoid dislodgement of the TPV

during DCS removal.

• Once deployment is initiated, retrieval of the TPV from the patient is not recommended.

Retrieval of a partially deployed valve may cause mechanical failure of the delivery catheter system or may cause injury to the patient. Refer to Section 5.0 for a list of potential adverse events associated with the Harmony TPV implantation.

• During deployment, the DCS can be advanced or withdrawn prior to the outflow struts

protruding from the capsule. Once the TPV struts contact the anatomy during deployment, it is not recommended to reposition the device. Advancing the catheter forward once the TPV struts make contact with the anatomy may lead to an undesired deployment or may cause damage to or failure of the TPV and injury to the patient. Refer to Section 5.0 for a list of potential adverse events associated with the Harmony TPV implantation.

• Physicians should use judgment when considering repositioning of the TPV (for example,

using a snare or forceps) once deployment is complete. Repositioning the bioprosthesis is not recommended, except in cases where imminent serious harm or death is possible (for example, occlusion of the main, left, or right pulmonary artery). Repositioning of a deployed valve may cause damage to or failure of the TPV and injury to the patient. Refer to Section

5.0 for a list of potential adverse events associated with the Harmony TPV implantation.

• Ensure the capsule is closed before DCS removal. If increased resistance is encountered

when removing the DCS through the introducer sheath, do not force passage. Increased resistance may indicate a problem and forced passage may result in damage to the device and harm to the patient. If the cause of resistance cannot be determined or corrected, remove the DCS and introducer sheath as a single unit over the guidewire, and inspect the DCS and confirm that it is complete.

• If there is a risk of coronary artery compression, assess the risk and take the necessary

precautions.

• Endocarditis is a potential adverse event associated with all bioprosthetic valves (Chapter 5).

Patients should make their health care providers aware that they have a bioprosthetic valve before any procedure. Postprocedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis.

• Prophylactic antibiotic therapy is recommended for patients receiving a TPV before

undergoing dental procedures.

• Postprocedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical

judgment and/or institutional protocol.

• Excessive contrast media may cause renal failure. Preprocedure, measure the patient’s

creatinine level. During the procedure, monitor contrast media usage.

• Conduct the procedure under fluoroscopy. Fluoroscopic procedures are associated with the

risk of radiation damage to the skin, which may be painful, disfiguring, and long-term.

5.0 Potential complications/adverse events

Potential risks associated with the implantation of the Harmony TPV may include, but are not limited to, the following:

• Death

• Valve dysfunction

• Tissue deterioration

• Hematoma

• Heart failure

• Cerebrovascular incident

• Perforation

• Rupture of the RVOT

• Compression of the aortic root

• Compression of the coronary arteries

• Sepsis

• Pseudoaneurysm

• Erosion

• Stent fracture

• Arrhythmias

• Device embolization or migration

• Pulmonary embolism

• Occlusion of a pulmonary artery

• Laceration or rupture of blood vessels

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