LeMaitre AlboGraft Mode D'emploi page 6

et al.1 published 10-year data on primary, primary assisted and secondary patency rates of 28%, 49% and
49% for Dacron grafts. Hsu et. al2 also showed survival rates of 59% out to 10 years post implant.
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 AlboGraft:
Return of the shipment to LeMaitre Vascular depends on 3 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?
3. Has the clinician obtained consent from the patient for the sample to be returned to the
manufacturer for research purposes?
In the event that the response to question 1 or 2 is affirmative, 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:
1. If possible, perform a CT or Ultrasound scan of the device to document patency.
2. LeMaitre Vascular can accept clinical information that is patient-anonymized. LeMaitre Vascular
requests information including:
a) The original diagnosis which resulted in use of the implant,
b) The patient's medical history relevant to the implant, including the hospital or clinic at which
the device was implanted.
c) The patient's implant experience prior to implant removal.
d) The hospital or clinic at which the explantation was done, and date of retrieval.
Explantation:
1. Explanted AlboGraft grafts should be directly transferred to a sealable container filled with a
solution of alkaline buffered 2% glutaraldehyde or 4% formaldehyde prior to shipment.
2. Cleaning of explanted grafts should be minimal if necessary. Proteolytic digestion should not be
used in any circumstances.
3. AlboGraft explants should not be decontaminated under any circumstances. DO NOT autoclave the
sample or use ethylene oxide gas to decontaminate.
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.
Material that is absorbent and is cushioning should be selected for isolating the sealable container
inside the secondary packaging. Primary and secondary packaging must then be packaged inside
an outer package.
2. Explants in sealed primary containers should be labeled with an ISO 7000-0659 Biohazard symbol.
The same symbol should be attached to the secondary packaging and to the outer packaging.
Outer packaging should also be labelled with Name, Address and Telephone Number of Sender,
and the statement, "Upon discovery of damage or leakage, the package should be isolated and
sender notified".
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