COOK Medical Zilver, Инструкция по эксплуатации

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• Manipulation of the Zilver Vascular Stent requires fluoroscopic control.
• Do not use power injection systems with the delivery system.
• Before insertion of the dilation catheter, appropriate antiplatelet and anticoagulant
therapy should be administered.
• Use in patients with a history of contrast sensitivity is not recommended unless the
patient can be adequately premedicated.
• Bench testing suggests that an increased potential for strut fracture may be associated with
overlapping of Zilver Vascular Stents in the peripheral vasculature, while animal studies
involving implantation of overlapped Zilver Vascular Stents in iliac arteries did not result in
any detected strut fractures. Clinical data characterizing the incidence of fractures in
implanted Zilver Vascular Stents are not available.
• The long-term outcome following repeat dilatation of endothelialized stents is
unknown at present.
• Safety and effectiveness have not been demonstrated in:
• Patients with a history of bleeding diathesis or coagulopathy
• Patients with a history of iliac aneurysm
• Patients with a known pregnancy
• Lesions located within or beyond a bypass graft
• Pediatric patients
Stent Handling
• Do not attempt to remove the stent from the delivery system before use.
• Do not expose any part of the delivery system to organic solvents (e.g., alcohol).
• This device is designed for single use only. Attempts to reprocess, re-sterilize, and/or
reuse may lead to device failure and/or transmission of disease.
• Carefully inspect the sterile package and stent system prior to use to verify that neither
has been damaged during shipment.
• Use the stent system prior to the expiration date specified on the package.
Stent Placement
• Ensure that the red safety lock is not removed until ready for final stent release.
• Deploy the stent over an extra stiff or ultra stiff wire guide.
• Do not push the hub toward the handle during deployment.
• Do not rotate any part of the system during deployment.
• Avoid stent placement that may obstruct access to a vital side branch.
• If placement of multiple stents is required in a patient, to cover the length of the lesion,
the distal area of narrowing should be stented first, followed by the proximal locations
(i.e., a second stent should be placed proximally to the previously placed stent). Stents
placed in tandem must overlap to allow for complete coverage of the lesion.
• When more than one stent is required, resulting in stent-to-stent contact, stent
materials should be of similar composition to avoid the possibility of dissimilar metal
corrosion.
• Once stent deployment has begun, the stent must be fully deployed.
• Repositioning of the Zilver Vascular Stent is not possible since the delivery system’s
outer sheath cannot be re-advanced over the stent once deployment begins.
• Overstretching of the artery may result in rupture and life-threatening bleeding. Do not
overstretch the stent.
Stent/System Removal
Do not advance sheath after stent has been deployed. Delivery system can be removed
without the need to recapture tip.