It was reported to gore that patient underwent endovascular treatment for a critical limb ischemia with a gore-tex® vascular graft - thin-walled removable ringed.It was stated that the prosthesis was implanted on (b)(6) 2019 as a below-the-knee femoro-popliteal bypass.It was reported that the clinical history takes notes of several revascularizations¿ surgeries in the context of ischemia.It was stated that on (b)(6) 2019, after about 1 month, two segments of the prosthesis were explanted due to infection to staphylococcus méti-s.
|
H6 evaluation codes investigation findings 213 refers to the product history review.A review of the manufacturing records indicated the lot met all pre-release specifications.Explant investigation (ei): the following is a summary of the ei observations: tissue present: yes.Segment 1 (19-112): the segment consisted of a gore-tex vascular graft (thin wall removable ring) fragment.The abluminal surface was generally devoid of tissue, except for multi-focal plaques of red/brown tissue.Both extremities were transected.Extremity a was transected in a non-uniform manner, as evident by cross-sectional view.The luminal view presented with dark brown/red and tan tissue occluding the lumen.Extremity b was ovular in shape and the luminal view presented in an unobstructed manner.The luminal patency could not be determined with the images/information provided.Segment 2 (19-113): the segment consisted of a gore-tex vascular graft fragment (type not provided) transected at an angle and connected to a dacron graft (presumptive) via blue running sutures (presumptive prolene®).The blue orientation line was consistent with that of a gore non-stretch vascular graft.The dacron graft was also connected to pink/red/brown native tissue via blue running sutures.The abluminal surface was generally devoid of tissue, except for minimal scattered plaques of red/brown tissue.Dark brown staining was observable on the abluminal surface.A partial, transverse transection, which was closed via blue, monofilament running suture, was present at approximately mid-graft.Multiple areas with evenly spaced serration marks, consistent with grasping/pulling with forceps/clamps, were present around the partial transection on the abluminal surface.Extremity a was transected and ovular in shape and the luminal view presented with brown/red and tan tissue occluding the lumen.The luminal patency could not be determined with the images/information provided.Material disruptions (i.E., transections, forceps marks, running suture) are consistent with those caused by surgical instrumentation (i.E., scalpel/scissors, forceps/clamps, suturing needle) likely used during a surgical procedure.The returned segments could not be correlated to a specific surgical or clinical event, from the information provided.Request for additional analysis: no.Reason: based on the ei¿s review of the third party report and reason for removal (infection), no additional analysis is requested.
|