LeMaitre AnastoClip GC Instructions D'utilisation page 5

use of the AnastoClip applier is contraindicated.
3. Do not use the AnastoClip applier if all the tissue layers cannot be completely symmetrically everted
prior to application of the clip.
4. Do not use the AnastoClip applier on tissue that is too friable for use of sutures.
5. The tissue must comfortably fi t within the confi nes of the jaws, or use of the applier is
contraindicated.
Complications
• Infection
• Pain/swelling
• Tissue damage
• Blood leakage
• Hemorrhage
• Embolism
• Stenosis
• Intimal dissection
• Thrombosis/occlusion
• Anastomosis rupture
• Dehiscence
Resterilization/ Re-use
These devices are single-use only. Do not reuse, reprocess, or re-sterilize. The cleanliness and sterility
of the re-processed device cannot be assured. Reuse of the devices may lead to cross contamination,
infection, or patient death. The performance characteristics of the devices may be compromised due
to reprocessing or re-sterilization since the devices were only designed and tested for single use. The
shelf life of these devices is based on single use only.
Safe Handling and Disposal
If serious medical incidents should arise during use of this medical device, users should notify both
LeMaitre Vascular and the Competent Authority of the country where the user is located.
This product contains no sharps, heavy metals or radioisotopes, and is not infectious or pathogenic.
No special requirements for disposal are evident. Please consult local regulations to verify proper
disposal.
Packaging and Shipping of Explanted AnastoClips:
Return of the shipment to LeMaitre Vascular depends on 2 crucial questions:
1. Is the explant obtained from a patient with a known or presumed pathogenic condition at the time
of the explant?
2. Is the explant obtained from a patient that has a known treatment history that involves therapeutic
radionuclides within the last 6 months?
In the event that the response to question 1 or 2 is affi rmative, LeMaitre Vascular does not provide
adequate guidance for shipment. THESE EXPLANTS SHOULD NOT BE RETURNED TO LEMAITRE VASCULAR
UNDER ANY CIRCUMSTANCES. In these cases, the explant should be disposed according to local
regulations.
For explants that do not have pathogenic or radiologic hazards, please use the following:
Pre-explantation:
LeMaitre Vascular can accept clinical information that is patient-anonymized.
LeMaitre Vascular requests information including:
1. The original diagnosis which resulted in use of the implant,
2. The patient's medical history relevant to the implant, including the hospital or clinic at which the
device was implanted.
3. The patient's implant experience prior to implant removal.
4. The hospital or clinic at which the explantation was done, and date of retrieval.
Explantation:
1. Explanted AnastoClips should fi rst be cleaned using one of the following:
a. Intense water rinse, followed by transfer to 70-80% ethanol, or
b. Cleaning in isopropanol with subsequent ultrasonic treatment, or
c. Cleaning in proteolytic enzyme solution, or
d. Cleaning in sodium hypochlorite solution (50-60 mg/l), or
e. Cleaning in 3% hydrogen peroxide.
2. Explanted AnastoClips should then be decontaminated with steam autoclaving or ethylene oxide.
3. AnastoClips should be packaged dry.
Packaging:
1. Explants should be sealed and packed in a manner that minimizes potential for breakage,
contamination of the environment or exposure to those handling such packages during transit.
The sealed primary container should be placed inside secondary packaging. Primary and secondary
packaging must then be packaged inside an outer package, which must be a rigid, fi berboard box.
• Necrosis
• Seroma
• Anastomotic insuffi ciency
• Pseudoaneurysm
• Nerve injury
• Steal phenomenon
• Intimal hyperplasia
• Cerebrospinal fl uid (CSF) leak
• Pseudomeningocele
• Neuropathic pain
• Spinal infarction
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