According to the report, "only heard information that there had been 3 revisions on patients who previously received a hero graft." additional information was received which indicated the hospital had "performed five hero graft implantations in five patients.We have performed five revisions in four patients." this report represents the first of four patients.According to the surgeons, "the first patient that received the hero graft was a (b)(6) year old woman, [lot numbers] hero 1001 h14vc041, [hero] 1002 h14av015, [hero] 1003 h14ak005.Implantation was performed on the (b)(6) 2014 [(b)(6) 2014], the first revision for graft thrombosis was on (b)(6) 2015 [(b)(6) 2015], the second also for graft thrombosis on (b)(6) 2015 [(b)(6) 2015].It is our impression that the thrombosis was due to intimal hyperplasia at the titanium connector between the eptfe prosthesis and the venous outflow component of the hero graft." this medwatch is submitted for product code hero 1001; however, all product codes were investigated.The manufacturing records for lots h14vc041, h14av015, and h14ak005 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.A review was performed of the available information.At this time, the role of the hero graft in these revisions cannot be determined with the available information, although graft revision/replacement is an established treatment for arteriovenous (av) graft complications.Thrombosis is the most common cause of vascular access dysfunction.Thrombosis is a known potential complication of the hero graft and adequate precautions and warnings are provided in the instructions for use (ifu).The risk of thrombosis is influenced by compliance with hemodialysis schedule and patient medical history.For example, hypercoagulability states or inadequately maintained anticoagulation therapy could contribute to an increased risk of thrombosis.Precautions regarding inadequate anticoagulation are provided in the ifu.Medical history was not available for these cases of thrombosis/revision.For these 4 cases of thrombosis in 3 patients, the surgeon believed the thrombosis was "due to intimal hyperplasia at the titanium connector." operative notes for the original hero implant procedures and the revisions were not available; details on the exact revision performed in each case are therefore unknown.Samples were also not received and it cannot be determined if intimal hyperplasia was the cause of the thrombosis events.At this time, the cause of the intimal hyperplasia and the following thrombosis events are unknown as the details of the cases are largely unavailable.
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According to the report, "only heard information that there had been 3 revisions on patients who previously received a hero graft." additional information was received which indicated the hospital had "performed five hero graft implantations in five patients.We have performed five revisions in four patients." this report represents the first of four patients.According to the surgeons, "the first patient that received the hero graft was a (b)(6) year old woman, [lot numbers] hero 1001 h14vc041, [hero] 1002 h14av015, [hero] 1003 h14ak005.Implantation was performed on the (b)(6) 2014 [(b)(6) 2014], the first revision for graft thrombosis was on (b)(6) 2015 [(b)(6) 2015], the second also for graft thrombosis on (b)(6) 2015 [(b)(6) 2015].It is our impression that the thrombosis was due to intimal hyperplasia at the titanium connector between the eptfe prosthesis and the venous outflow component of the hero graft." this medwatch is submitted for product code hero 1001; however, all product codes were investigated.
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