English; Intended Purpose; Contraindications - Cordis Precise Pro Rx Gebrauchsanleitung

PPE Specification
Labeling Specification
Precure Pro Rx OUS Carotid IFU

English

STERILE. Sterilized with ethylene oxide gas. Nonpyrogenic. Radiopaque. For one use
only. Do not resterilize. Store in a cool, dark, dry place. Not for sale in the U.S.A.
I. Device Name
The device brand name is Cordis PRECISE PRO RX™ Nitinol Stent System.
II. Description
The Cordis PRECISE PRO RX Nitinol Stent System consists of a nitinol (Maximum Stent
Composition: Nickel 57.0% weight/weight, Titanium 45.5% weight/weight) self-expanding
stent preloaded on a .065" (1.65 mm) or .078" (1.98 mm) sheathed delivery system. The
delivery system consists mainly of an inner shaft and an outer sheath with radiopaque
markers, and a Tuohy Borst valve. The inner shaft consists of a support member and wire
lumen. The proximal portion of the support member is comprised of a hub connected to a
stainless steel wire and hypotube and distally of a stainless steel coil. The wire lumen originates
distally in a catheter tip and terminates proximally at a guidewire exit port designed to accept
a .014" (0.36 mm) guidewire. The outer sheath has a proximal shaft and distal outer sheath
with a nominal working length of 135 cm. The self-expanding PRECISE™ stent is constrained
within the space between the inner shaft and the distal outer sheath, located between distal
and proximal stent markers on the inner shaft. The stent expands to its unconstrained diameter
when released from the deployment catheter into the vessel. Upon deployment, the stent
forms an open lattice and pushes outward on the luminal surface, helping to maintain the
patency of the vessel. Due to the self-expanding behavior of nitinol, the stents are indicated for
placement into vessels that are 1–2 mm smaller in diameter than the unconstrained diameter
of the stent. Device depictions and components are provided in Figure 1.
III. Intended Purpose
The Cordis PRECISE PRO RX Nitinol Stent System is a single-use device consisting of
an endovascular stent and sheath delivery system, intended to deliver a self-expanding
endovascular stent to the carotid artery(ies).
The stent component imparts an outward radial force on the luminal surface of the vessel wall
restoring vascular patency.
IV. Indications for Use
The Cordis PRECISE PRO RX Nitinol Stent System is indicated for use in patients with stenotic
lesions of the carotid artery(ies).
V. Patient Target Group
The patient target group includes individuals with stenotic lesions of the carotid artery(ies).
The patient target group of this device is based on the patient's anatomy and compatibility
with the device.
VI. Contraindications
Generally, contraindications to PTA are also contraindications for stent placement.
Contraindications include, but may not be limited to:
• Patients with highly calcified lesions resistant to PTA.
• Patients with a target lesion with a large amount of adjacent acute or subacute
thrombus.
• Patients with uncorrected bleeding disorders.
• Stenting of intra-cranial arteries.
• Patients with known allergies to nitinol.
VII. Warnings
• Only physicians who have received appropriate training for carotid stenting and who are
familiar with the principles, clinical applications, complications, side effects and hazards
commonly associated with carotid interventional procedures should use this device.
• The black dotted pattern on the grey temperature exposure indicator, found on the
pouch, must be clearly visible. Do not use if entire circle is completely black as the
unconstrained stent diameter may have been compromised.
The Cordis PRECISE PRO RX Nitinol Stent System is intended for single use only. DO NOT
•
resterilize and/or reuse the device.
• This product is designed and intended for single use. It is not designed to undergo
reprocessing and re-sterilization after initial use. Reuse of this product, including after
reprocessing and/or re-sterilization, may cause a loss of structural integrity which could
lead to a failure of the device to perform as intended and may lead to a loss of critical
labeling/use information all of which present a potential risk to patient safety.
• Do not use if the pouch is opened or damaged.
• Use the stent and delivery system prior to the "Use By" date specified on the package.
Do not use with Ethidol™ or Lipiodol™ contrast media, which may adversely affect the
•
stent delivery system.
• Do Not Use a Leaflet-Type Valve with The Sheath Introducer/Guiding Catheter.
• In the event of complications such as infection, pseudoaneurysm or fistulization, surgical
removal of the stent may be required. Standard surgical procedure is appropriate.
• In patients requiring the use of antacids and/or H2-antagonists before or immediately
after stent placement, oral absorption of antiplatelet agents (e.g. aspirin) may be
adversely affected.
• Do not expose the delivery system to organic solvents (e.g. alcohol) as structural integrity
and/or function of the device may be impaired.
• Use of a smaller than indicated accessory device can lead to introduction of air into that
device as the stent delivery system is advanced, which may not be removed during air
aspiration.
• The stent is not designed for dragging or repositioning.
• Once the stent is partially deployed, it cannot be recaptured using the stent delivery system.
• As with any type of vascular implant, infection, secondary to contamination of the stent,
may lead to thrombosis, pseudoaneurysm or rupture.
• The stent may cause a thrombus, distal embolization or may migrate from the site of
implant down the arterial lumen. Appropriate sizing of the stent to the vessel is required
to reduce the possibility of stent migration. In the event of thrombosis of the expanded
stent, thrombolysis and PTA should be attempted.
• Overstretching of the artery may result in rupture and life-threatening bleeding.
• Persons with allergic reaction to nickel titanium (Nitinol) may suffer an allergic response
to this implant.
• This device contains the following substance defined as CMR 1A and/or CMR 1B and/
or endocrine disrupting substances in a concentration above 0.1% weight by weight:
Cobalt; CAS No. 7440-48-4; EC No. 231-158-0.
It is not recommended that the stent be used in patients with the following characteristics:
• Patients with poor renal function, who, in the physician's opinion, may be at risk for a
reaction to contrast medium.
• Pregnant patients.
• Patients with bleeding disorders or patients who cannot receive anticoagulation or
antiplatelet aggregation therapy.
• Patients with perforated vessels evidenced by extravasation of contrast media.
• Patients who have aneurysmal dilation immediately proximal or distal to the lesion.
• Patients whose lesion(s) may require more than two stents.
• Patients with total occlusion of the target vessel.
• Patients with lesions of the ostium of the common carotid.
• Patients with highly calcified lesions resistant to PTA.
• Concurrent treatment of bilateral lesions.
• Patients experiencing acute ischemic neurologic stroke or who experienced a stroke
within 48 hours.
• Patients with an intracranial mass lesion (i.e. abscess, tumor, or infection) or aneurysm
(> 9 mm).
• Patients with arterio-venous malformations in the territory of the target carotid artery.
• Patients with known peripheral vascular, supra-aortic or internal carotid artery tortuosity
that would preclude the use of catheter-based techniques.
• When multiple stents are used, they should be of similar composition.
• Long-term outcomes following repeat dilatation of endothelialized stents are unknown.
VIII. Precautions
• The delivery system is not designed for the use of power injection systems. Use of power
injection may adversely affect device performance.
• When catheters are in the body, they should be manipulated only under fluoroscopy.
• Radiographic equipment that provides high quality images is needed.
• When treating multiple lesions, the distal lesion should be initially stented, followed
by stenting of the proximal lesion. Stenting in this order obviates the need to cross the
proximal stent in placement of the distal stent and reduces the chance for dislodging
stents which may have already been placed.
• Recrossing a deployed stent with adjunct devices must be performed with caution.
• In the event of thrombosis of the expanded stent, thrombolysis and PTA should be
attempted.
• Venous access should be available during carotid stenting in order to manage
bradycardia and/or hypotension either by pharmaceutical intervention or placing of a
temporary pacemaker, if needed.
• Both PRECISE PRO RX Nitinol Stent Systems are shipped with the Tuohy Borst valve in
the OPEN position (see "Preparation of the Stent Delivery System").
• Prior to stent deployment remove all slack from the catheter delivery system (see "Stent
Deployment").
• Ensure that the catheter system is flushed according to the steps outlined in
"Introduction of Stent Delivery System" and "Preparation of Stent Delivery System."
Failure to do so could result in air entering the access catheter.
• Ensure that there is a tight seal between the PRECISE PRO RX catheter and the valve
for the access catheter during aspiration. Failure to do so could result in air entering the
access catheter.
• Store in a cool, dark, dry place.
• Fractures of this stent may occur. Fractures may also occur with the use of multiple
overlapping stents. Care should also be taken when deploying the stent as excessive force
could, in rare instances, lead to stent deformation and/or fracture.
• The safety and effectiveness have not been demonstrated in patients who are pregnant
or lactating and/or pediatric patients.
IX. Potential Adverse Events
Adverse Events (in alphabetical order) that may be associated with the use of the Cordis
PRECISE Nitinol Stent System when used in conjunction with the ANGIOGUARD™ XP Emboli
Capture Guidewire include, but may not be limited to:
• Air embolism
• Allergic/anaphylactoid reaction
• Aneurysm
• Angina/coronary ischemia
• Arrhythmia (including bradycardia, possibly requiring need for a temporary or
permanent pacemaker)
• Arterial occlusion/restenosis of the treated vessel
• Arterial occlusion/thrombus, at puncture site
• Arterial occlusion/thrombus, remote from puncture site
• Arteriovenous fistula
• Bacteremia or septicemia
• Cerebral edema
• Damage to emboli capture device
• Death
• Embolization, arterial
• Embolization, stent
• Emergent repeat hospital intervention
• Fever
• GI bleeding from anticoagulation/antiplatelet medication
• Hematoma bleed, puncture site
• Hematoma bleed, remote site
• Hemorrhage
• Hyperperfusion syndrome
• Hypotension/hypertension
• Infection
• Intimal injury/dissection
• Ischemia/infarction of tissue/organ
• Local infection and pain at insertion site
• Malposition (failure to deliver the stent to the intended site)
11060616 | Rev:13
Released: 26 Jan 2022
CO: 100553075
Release Level: 4. Production
7