Lot/serial numbers were not provided, therefore, a review of the manufacturing records could not be conducted.If lot/serial numbers are obtained, the review will be included on the final report.
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On november 5, 2016, during a presentation titled "heparin-coated graft bypass for occlusive peripheral artery disease: long-term results of cbas technology", it was reported to gore that gore® propaten® vascular grafts, which were used for a bypass procedures in order to treat occlusive peripheral artery disease, led to occlusions or thromboses, occurring less than or equal to 30 days of primary procedure, in 4 patients.
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