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the introduction, manipulation, deployment, and eventual removal of the WRAPSODY
Delivery Catheter.
•
Repositioning of the WRAPSODY Delivery Catheter may be necessary prior to deploying
the endoprosthesis.
•
Once deployed, the WRAPSODY Endoprosthesis cannot be retracted or resheathed onto
the delivery catheter.
•
Placing a endoprosthesis across a side branch may obstruct blood flow and prevent or
hinder future access or other procedures.
•
Placing a endoprosthesis beyond the ostium of the cephalic vein into the axillary/
subclavian vein may hinder or prevent future access and is not recommended.
•
Do not use the WRAPSODY device if it cannot be flushed prior to use. Guide wire lumen
and endoprosthesis Pod flushing are required prior to insertion or reinsertion.
•
After use, the WRAPSODY Delivery Catheter is a potential biohazard. Handle and dispose
of in accordance with accepted medical practice and with applicable local, state and
federal laws and regulations.
•
Inadvertent, partial, or failed deployment or migration of the WRAPSODY Endoprosthesis
may require surgical intervention.
•
The safety and effectiveness of the device when placed in the Superior Vena Cava has not
been evaluated.
•
The safety and effectiveness of the device has not been evaluated in pediatric patients.
•
Do not use in patients with uncorrectable coagulation disorders.
•
Do not use in patients when there is clinical evidence of infection which could spread to
the implanted endoprosthesis.
•
Do not use in patients with functional relevant obstruction of the inflow path, poor
outflow or no distal runoff.
•
The WRAPSODY Endoprosthesis is not designed to treat fresh, soft thrombotic or embolic
material.
PRECAUTIONS
•
Follow the Instructions for Use with all devices that are used together with the Merit
WRAPSODY Endoprosthesis.
•
The WRAPSODY Delivery Catheter is not intended for any use except to deploy the
WRAPSODY Endoprosthesis.
•
The WRAPSODY Delivery Catheter can only deploy the WRAPSODY Endoprosthesis after
the safety clip is removed. This should not be done until the WRAPSODY Endoprosthesis is
about to be released. See DIRECTIONS FOR USE.
•
Higher deployment forces may be encountered on longer lengths of WRAPSODY
Endoprosthesiss.
•
The WRAPSODY Endoprosthesis should not be balloon expanded beyond its stated
diameter. Refer to Table 1 for the appropriately sized balloon diameter.
•
Do not use a balloon that is longer than the labeled length of the WRAPSODY
Endoprosthesis.
•
When passing any accessory device through the WRAPSODY Endoprosthesis use caution
and ensure that the WRAPSODY Endoprosthesis does not dislodge.
•
Do not withdraw or reposition a balloon catheter within the lumen of the WRAPSODY
Endoprosthesis unless the balloon is completely deflated.
•
The safety and effectiveness of the device when placed across an aneurysm or a pseudo-
aneurysm has not been evaluated.
•
The safety and effectiveness of the device has not been evaluated in areas of extreme
flexion such as the clavicle, popliteal fossa, and antecubital fossa.
•
Testing has not been conducted for the use of the WRAPSODY Endoprosthesis in an
overlapped condition with bare metal stents or with other competitive endoprosthesiss
(or covered stents).
PRECAUTION STATEMENT
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or
resterilization may compromise the structural integrity of the device and/or lead to device failure
which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization
may also create a risk of contamination of the device and/or cause patient infection or cross
infection, including, but not limited to, the transmission of infectious disease(s) from one patient
to another. Contamination of the device may lead to injury, illness or death of the patient.
Any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the superintendent authority of the applicable Member State.
CLINICALLY RELATED COMPLICATIONS
All clinical complications that have been reported in association with conventional vascular
stents and endoprosthesiss may also occur during or after insertion of the WRAPSODY
Endoprosthesis. These include allergic reaction, aneurysm, arm or hand oedema, bleeding at
access site, cellulitis, cerebrovascular accident, congestive heart failure, face or neck oedema,
fever, haematoma, haemoptysis, haemorrhage, infection, pain, perforation, prolonged bleeding,
pseudoaneurysm, rash, reaction to contrast, restenosis requiring intervention, sepsis, steal
syndrome, endoprosthesis embolism, thrombotic and non-thrombotic occlusion, vasospasm,
vasoconstriction, ventricular fibrillation, vessel rupture, and death.
DEVICE RELATED COMPLICATIONS
All device related complications that have been reported in association with conventional
vascular stents and endoprosthesiss may also occur when using the WRAPSODY Endoprosthesis.
These include bond joint failure, delivery system kinking, detachment of part, failure to deploy,
high deployment forces, inability to track to the target location, inaccurate deployment,
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