It was reported to gore that the patient presented on (b)(6) 2021 with massive bleeding due to arterial perforation with a large sheath during endovascular treatment for a transcatheter aortic valve implantation (tavi).In an emergency surgical treatment an ilio-femoral bypass was performed with a gore-tex® stretch vascular graft thin-walled.Reportedly, on (b)(6) 2021, after about one month, the prosthesis was explanted due to an bacterial wound infection with proteus mirabilis, morganella morganiiet and enterococcus faecalis bacteries.It was stated that the explanted device was replaced with an allograft.
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Explant investigation: the device was returned to geprovas for investigation.Submitted in formalin was a gore-tex® stretch vascular graft fragment.The scope and results of the investigation were summarized, and a report was submitted to w.L.Gore & associates.An explant scientist at w.L.Gore & associates reviewed the report.Explant scientist observations: the graft fragment was reported to measure 53 mm in length with both ends transected.The ablumen was covered in thin light tan tissue and the blue alignment marks were clearly visible.Both ends of the graft had regions of blue monofilament suture in a continuous running pattern which appear to be anastomosed to native light tan to dark brown tissue.The lumen at extremity a is completely covered by tissue rendering the graft non-visible, extremity b is partially covered by tissue, the portion of lumen visible was generally devoid of tissue.The patency of the graft fragment could not be clearly determined based on the analysis or images provided.Material disruptions (e.G., transections and sutures) were consistent with those caused by surgical instrumentation (e.G., scalpel, scissors, suture) used during a surgical procedure.Based on the explant scientist¿s review of the geprovas report, no additional analysis is requested.The reported reason for removal was infection, type and source were not provided, and there was no accusation of infection being device related from the physician.
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