Potential Adverse Events - COOK Medical Zilver PTX Instrucciones De Uso

POTENTIAL ADVERSE EVENTS

Potential adverse events that may occur include, but are not limited to,
the following:
• Allergic reaction to anticoagulant and/or antithrombotic therapy or contrast
medium
• Allergic reaction to nitinol
• Arterial aneurysm
• Arterial rupture
• Arterial thrombosis
• Arteriovenous fistula
• Atheroembolization (Blue Toe Syndrome)
• Death
• Embolism
• Hematoma/hemorrhage
• Hypersensitivity reactions
• Infection
• Infection/abscess formation at access site
• Ischemia requiring intervention (bypass or amputation of toe, foot or leg)
• Pseudoaneurysm formation
• Renal failure
• Restenosis of the stented artery
• Stent embolization
• Stent malapposition
• Stent migration
• Stent strut fracture
• Vessel perforation or rupture
• Worsened claudication/rest pain
Although systemic effects are not anticipated, refer to the Physicians' Desk
Reference for more information on the potential adverse events observed
with paclitaxel.
Potential adverse events, not described in the above source, may be unique to
the paclitaxel drug coating:
• Allergic/immunologic reaction to the drug coating
• Alopecia
• Anemia
• Blood product transfusion
• Gastrointestinal symptoms
• Hematologic dyscrasia (including leukopenia, neutropenia,
thrombocytopenia)
• Hepatic enzyme changes
• Histologic changes in vessel wall, including inflammation, cellular damage,
or necrosis
• Myalgia/Arthralgia
• Myelosuppression
• Peripheral neuropathy
PRODUCT RECOMMENDATIONS
Placement of this vascular stent requires advanced skills in interventional
vascular procedures. The following instructions will give technical guidance,
but do not obviate formal training in the use of the device.
ZILVER® PTX® DRUG ELUTING PERIPHERAL STENT AND
DELIVERY SYSTEM
b
i
g
a. Handle
b. Hub
c. Safety Lock
d. Delivery System: Outer Sheath
e. Tip of Delivery System Inner Catheter
f. Side-arm Flushing Port
g. Metal Cannula
h. Radiopaque Markers on the Delivery System
i. Inner Support Stylet
j. Gold Radiopaque Markers
c
a d
f
j
4
e
h h
j
Fig. 1