Corrected data: block h6, result code 180 replaced by 3221 following additional information provided by a second laboratory and conclusion of our corporate medical officer (see details below).Additionnal manufacturer narrative: (10/3221) an additional analysis has been performed by a second external independent laboratory following request by our corporate medical officer to better understand the case before conclusion.Their observations are as follows: "the analysis of the explanted graft shows a more important textile ageing of the left leg than on the rest of the graft.Moreover, this area corresponds to the blood leakage area observed by the surgeon.However, the macro- and microscopical analyses followed with sem did not reveal any holes nor broken yarn that could be responsible for the pseudo-aneurysm growing.No needle puncture is observed.Interstices between yarns could be observed locally, which is not unusual in grafts after 11 years of implantation due to the cyclic extension undergone by the textile structure in vivo.One can however expect that the tissue ingrowth would probably have clogged these holes.Regarding the remeshing line area of the graft, observations bring out that the yarns are looser in that zone and that the textile structure appears to be consequently locally less tight.It can however not be concluded, based on the available data, that the expected increased permeability in that zone would be responsible for aneurysm formation." they concluded that: "thus, it cannot be concluded that the segment of the bypass received for analysis is implicated into the pseudoaneurysm growing but, as the anastomoses of the graft were not received, a part of the bypass was not analysed.So, it cannot be excluded that the needle puncture mentioned by the surgeon was on the unanalysed part of the graft." the results above were then sent to our corporate medical officer to have his final comments.His observations are as follows : "the most likely origin of a pseudoaneurysm is at the anastomotic level.The analysis provided by [the second laboratory] does not include the anastomotic site.The hypothesis presented by the surgeon cannot be supported by the findings however the portion of graft containing the hole may have not been included in the specimen received.Therefore it cannot be disregarded.Overall, i agree with the lab conclusions." (4315) the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.
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