In total three reports were submitted for the notified medical incident with the following lot numbers: lot #18219397; udi # (b)(4); mfr report #2017233-2018-00629, lot #18401042; udi # (b)(4); this report, lot #18410292; udi # (b)(4); mfr report #2017233-2018-00631.
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The patient presented with a popliteal artery aneurysm (4cm in diameter x 20 cm in length) on the left side which was intended to be treated with two gore® viabahn® endoprostheses.It was reported to gore that the placement of the two gore® viabahn® endoprostheses went uneventfully but that the angiography indicated that the two implanted medical devices did not exclude the entire length of the aneurysm.Therefore the decision was made to implant a third gore® viabahn® endoprosthesis.When the final angiography was performed, after the three gore® viabahn® endoprostheses were successfully implanted, it was noticed that the blood was standing still at the distal end of the implanted devices.Consequently, a percutaneous transluminal angioplasty was performed for the anterior tibial artery, the posterior tibial artery as well as for the peroneal artery.It was stated that the outflow appeared much better but that it was still not real fast.It was mentioned that even prior medical device implantation the blood flow was not really fast.After two days the patient presented with a cold leg where a thrombosis of the implanted gore® viabahn® endoprostheses was diagnosed and consequently treated with a venous bypass.
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