Medtronic INT22512UX Instructions for Use
Medtronic Integrity Coronary Stent System
INSTRUCTIONS FOR USE
CAUTION: Federal (USA) law restricts this product for sale by or on the order of a physician.
Integrity Coronary Stent System
Instructions for Use
Table of Contents
1.0 DEVICE DESCRIPTION...................................................................................................................... 2
2.0 INDICATIONS FOR USE..................................................................................................................... 3
3.0 CONTRAINDICATIONS...................................................................................................................... 3
4.0 WARNINGS AND PRECAUTIONS....................................................................................................3
5.0 POTENTIAL ADVERSE EVENTS ..................................................................................................... 5
6.0 INDIVIDUALIZATION OF TREATMENT....................................................................................... 5
7.0 PATIENT COUNSELING .................................................................................................................... 6
8.0 HOW SUPPLIED ................................................................................................................................... 6
9.0 DIRECTIONS FOR USE ...................................................................................................................... 7
10.0 IMAGING GUIDELINES ................................................................................................................. 14
12.0 SUMMARY OF CLINICAL STUDY............................................................................................... 15
DISCLAIMER OF WARRANTY ............................................................................................................ 25
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1.0 DEVICE DESCRIPTION
The Medtronic Integrity Coronary Stent System (Integrity Stent) consists of a
balloon-expandable intracoronary stent pre-mounted on either the MicroTrac Rapid
Exchange (RX) or MicroTrac Over-the-Wire (OTW) stent delivery system. The
balloon delivery system has two radiopaque markers to aid in the placement of the
stent during fluoroscopy. The Integrity Stent is manufactured from a cobalt alloy and
is formed from a single wire bent into a continuous sinusoid pattern and then laser
fused back onto itself (Figure 1). The stents are provided in multiple lengths and
diameters. Both delivery systems are compatible with 0.014 inch (0.36mm)
guidewires. The MicroTrac RX (Figure 2) and the MicroTrac OTW (Figure 3)
delivery systems have an effective length of 140cm.
Figure 1. Medtronic Integrity Stent
Figure 2: MicroTrac RX Delivery System (with Stent)
Figure 3: MicroTrac OTW Delivery System (with Stent)
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2.0 INDICATIONS FOR USE
The Integrity Coronary Stent is indicated for improving coronary luminal diameter in
patients with symptomatic ischemic heart disease due to discrete de novo or restenotic
lesions, with reference vessel diameters of 2.25–4.0 mm and ≤30 mm in length, using
direct stenting or predilatation.
3.0 CONTRAINDICATIONS
• Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.
• Patients who are judged to have a lesion that prevents complete inflation of an
angioplasty balloon or proper placement of a stent or stent delivery system.
4.0 WARNINGS AND PRECAUTIONS
The long-term effects of stents and the risks associated with lifelong carrying of these
implants are unknown. This lack of knowledge should be considered in making a
risk/benefit assessment for the patient prior to implantation.
• The Integrity Coronary Stent System is provided sterile, for one procedure only.
Do not resterilize. Use by the “Use By” date noted on the package.
• Only physicians who have received appropriate training should perform
implantation of the stent. Use of the Integrity Coronary Stent System requires
advanced coronary angioplasty technical skills. The instructions will give
technical guidance, but do not obviate the need for formal training in the use of
the device.
• Patients allergic to cobalt alloy may suffer an allergic reaction to this implant.
• Do not remove the stent from the stent delivery system; the stent can not be
removed and placed on another balloon catheter for deployment.
• Do not try to straighten a kinked shaft or hypotube. Straightening a kinked metal
shaft may result in breakage of the shaft. If the device is kinked, it should not be
used.
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• Significant amounts of air in the balloon may cause uneven expansion of the stent
and difficulty in deployment of the stent. Do not pre-inflate balloon prior to stent
deployment. Use balloon preparation technique described within this instructional
material.
• The Integrity Coronary Stent System does not provide for distal dye injections or
pressure measurements through the guidewire lumen.
• Expansion of the stent should not be undertaken if the stent is not appropriately
positioned in the vessel. If the position of the stent is not optimal, it should not be
expanded. (Refer to section 9.6 “Removal of an Unexpanded Stent”.)
• Incomplete deployment of the stent (i.e., stent not fully expanded) may cause
procedural complications resulting in patient injury.
• Advancement of an Integrity Coronary Stent System through a previously stented
segment may cause procedural complications resulting in patient injury.
• Placement of the stent has the potential to compromise side branch patency.
• Administer appropriate anticoagulant/antiplatelet and coronary artery vasodilator
therapy according to current medical guidelines and manufacturer’s instructions.
• Caution must be taken when using ancillary equipment, such as intravascular
ultrasound catheters, to avoid dislodgement or deformation of the stent.
• When multiple stents are required, stent materials should be of similar
composition. Placing multiple stents of different materials in contact with each
other may increase the potential for corrosion. Data obtained from in vitro
corrosion tests using a Cobalt alloy stent (Medtronic Integrity BMS Coronary
Stent) in combination with a stainless steel alloy stent (Boston Scientific
Liberte™ Coronary Stent) do not suggest an increased risk of in vivo corrosion.
• When using two wires, care should be taken when introducing, torquing and
removing one or both guidewires to avoid entanglement. It is recommended that
one guidewire be completely withdrawn from the patient before removing any
additional equipment.
• Stent placement should only be performed at hospitals where emergency coronary
artery bypass graft surgery can be readily performed.
• Judicious selection of patients is necessary since the use of this device carries the
associated risk of subacute thrombosis, vascular complications and/or bleeding
events. Administration of appropriate anticoagulant, antiplatelet and coronary
vasodilator therapy is critical to successful stent implantation and follow-up.
• Subsequent restenosis may require repeat dilatation of the arterial segment
containing the stent. The long-term outcome following repeat dilatation of
endothelialized coronary stents is unknown at present.
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5.0 POTENTIAL ADVERSE EVENTS
The following complications may be associated with the use of coronary stenting
devices or PTCA:
• Acute myocardial infarction
• Allergic reaction to contrast medium/stent material/medications
• Arrhythmias (including ventricular fibrillation & ventricular tachycardia)
• Arteriovenous fistula
• Bleeding complications
• Cardiac tamponade
• Cerebrovascular accident/stroke
• Death
• Dissection of coronary artery
• Drug reactions
• Embolization (air, stent, tissue or thrombotic)
• Emergency coronary artery bypass graft surgery (CABG)
• Endocarditis
• Failure to deliver the stent
• Stent deformation, collapse or fracture
• Hematoma
• Hemorrhage requiring transfusion
• Injury of the coronary artery
• Myocardial ischemia/infarction
• Pain and tenderness at the insertion site
• Perforation
• Peripheral Ischemia
• Peripheral nerve injury
• Pseudoaneurysm (coronary/femoral/radial)
• Pyrogenic reaction
• Restenosis of the dilated artery or stented segment
• Sepsis/infection
• Short-term hemodynamic deterioration (hypotension/hypertension)
• Stent thrombosis or occlusion
• Total occlusion of coronary artery
• Unstable angina
• Vascular thrombosis
• Vessel dissection/perforation/spasm
6.0 INDIVIDUALIZATION OF TREATMENT
The risks and benefits described above should be carefully considered for each
patient before use of the Medtronic Coronary Integrity Stent System. Patient
selection factors to be assessed should include a judgement regarding risk of
prolonged anticoagulation. Stenting should be generally avoided in those patients at
heightened risk of bleeding (e.g., those patients with recently active gastritis or peptic
ulcer disease, See Contraindications). Each Integrity Stent must be sized appropriate
to fit the patient’s particular coronary anatomy. Proper sizing of the device (diameter
and length) is the responsibility of the physician and it is recommended that the
Integrity Stent cover the stenotic lesion. The risks and benefits previously described
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should be carefully considered for each patient before use of the Integrity Coronary
Stent System (Refer to section 5).
Co-morbidities that increase the risk of poor initial results or the risks of emergency
referral for bypass surgery (diabetes mellitus, renal failure, and severe obesity) should
be reviewed.
Thrombosis following stent implantation is affected by several baseline angiographic
and procedural factors. These include vessel diameter less than 3.0mm, interprocedural thrombosis, poor distal flow, and/or dissection following stent
implantation. In patients that have undergone coronary stenting, the persistence of a
thrombus or dissection is considered a marker for subsequent thrombotic occlusion.
These patients should be monitored very carefully during the first month after stent
implantation.
7.0 PATIENT COUNSELING
The physician should review the risks, benefits and potential adverse events when
counseling the patient about this device and procedure. Medtronic can provide
physicians with a Patient Guide which includes information on Medtronic, Inc., the
implant procedure and Medtronic coronary stents.
The Medtronic Integrity Coronary Stent System is packaged with additional specific
information:
• A Coronary Stent Implant Card that includes patient information, stent
implant information and MRI guidelines. All patients will be instructed to
keep this card in their possession at all times for procedure/stent
identification.
8.0 HOW SUPPLIED
• Package contains one coronary stent pre-mounted on a custom stent delivery
system with its accessories (a compliance chart, and a 29 gauge cannula and
looper). Sterilized by EtO gas diffusion. Sterile, non-pyrogenic in unopened,
undamaged packages. Store at room temperature. Use by the “Use By” date noted
on the package. It is intended for single use only. Do not resterilize.
WARNING: This device is single use. This device is intended to contact body
tissues. Do not reuse, reprocess or resterilize. Reprocessing may compromise the
structural integrity of this device. Reuse of this device creates a potential risk of
patient infections due to contamination. This contamination of the device may lead
to injury, illness or death of the patient.
CAUTION: Should there be damage to the package, do not use.
• The Medtronic Integrity Coronary Stent System is intended to perform as a
system. The Medtronic Integrity Stent is not designed to be crimped onto another
delivery device.
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9.0 DIRECTIONS FOR USE
Carefully inspect the sterile package before opening. It is not recommended that the
product be used after the “Use By” date. If the integrity of the sterile package has
been compromised prior to the product “Use By” date (e.g., damage of the package)
contact your local Medtronic Representative for return information. If the sterile
package appears intact, carefully remove the system from the package and inspect for
bends, kinks and other damage. Verify that the stent is located between the
radiopaque markers. Verify that there is no visible damage to the stent or to the
balloon. Do not use if any defects are noted.
9.1 Selection of Stent Size
Careful stent sizing is important to successful stenting. In general, the stent size
should be chosen to match the diameter of the reference vessel and to correspond
with the length of the lesion. Slight stent oversizing is preferable to undersizing.
CAUTION: The inflated balloon diameter measures slightly larger than the labelled
stent diameter to allow for stent recoil upon expansion.
9.2 Preparation of the Delivery System
Materials Required:
Quantity Material
Appropriate guiding cathete
1 20 cc syringe
Heparinized normal saline
1 0.36mm
0.014 inch) x 180 cm guidewire
1 Rotating hemostatic valve
Contrast medium diluted 1:1 with heparinized normal saline
1 Inflation device
1 Torque device
Optional Three-way stopcoc
• Remove the stent delivery system from the package. Special care must be taken
not to handle the stent or in any way disrupt its placement on the balloon. This is
most important during catheter removal from packaging, placement over
guidewire, and advancement through the rotating hemostatic valve and guiding
catheter hub. Excessive manipulation, e.g., rolling the mounted stent, may cause
dislodgement of the stent from the delivery balloon.
WARNING:
• Should there be movement of or damage to the stent, or to the balloon, do not
use.
• Do not attempt pre-inflation technique to purge balloon lumen.
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