W. L. GORE & ASSOCIATES, INC. GORE-TEX® STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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Device Problem
Contamination (1120)
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Patient Problems
Unspecified Infection (1930); Pseudoaneurysm (2605)
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Event Date 03/05/2020 |
Event Type
Injury
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Event Description
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A third party reported to w.L.Gore 6 associates, that an explanted eptfe vascular endograft was received for evaluation.They stated, that the eptfe vascular endograft was implanted in 2016 as a femoro-popliteal bypass in order to treat an acute ischemia.Reportedly, there was no pre-existing infection in the field of treatment.On (b)(6) 2020, the eptfe vascular endograft was explanted due to an anastomotic false-aneurysm and infection (unknown germ) and replaced by an allograft.They stated, that the brand name and the model type of the explant was not reported by the surgeon, but the macroscopic analysis before cleaning suggests it is a "w.L.Gore ring reinforced prosthesis".Is not possible to identify the device type from this description.It might be a gore-tex® stretch vascular graft with removable rings.
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Manufacturer Narrative
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As a best estimate, (b)(6) 2016, was selected as the date of implant.(b)(4).The serial number of the device remains unknown.Therefore, a review of the manufacturing records could not be performed.(b)(4) the explanting physician sent the device to a third party for evaluation.The final result is pending.Per instruction for use, section vi.Possible complications with the use of any vascular prosthesis complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: infection.
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Manufacturer Narrative
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H6-code 4112 and 213: the 3rd party provided an explant report which was review and evaluated by gore.The evaluation summary states the following: the reported reasons for removal were infection, type and source were not provided, and there was no direct association towards gore¿s device and the reason for removal from the physician, and anastomotic false aneurysm and none of the returned segments were identified as containing the anastomotic region of the explanted device.Additionally, the specimens returned to (b)(6) were severely disrupted during the explant process which hinders the ability to accurately assess the device materials.Segment 1: the graft fragment was reported to measure 57 mm in length and both ends were transected.The ablumen was primarily covered in a thick layer of light tan to brown and yellow (presumed adipose) tissue.Rings on the ablumen of the graft are visible however, the blue alignment marks were not visible in the images provided.The patency of the graft fragment cannot be determined based on the images provided.Segment 2: the graft fragment was hemi sectioned and reported to measure 24 mm in length with both ends transected and no attached rings.The abluminal surface had tissue similar to segment 1.The blue alignment marks were not clearly visible in the images provided.The luminal surface was generally devoid of tissue.Segment 3: the graft fragment was reported to measure 22 mm in length and both ends were transected.The ablumen was generally devoid of tissue except scattered plaques of light tan to brown tissue concentrated to extremity a, which had attached ring fragments and multiple evenly spaced serration marks present.The fragment had been compressed and the lumen was not visible.The patency of the graft fragment cannot be determined based on the analysis or images provided.Segment 4: the graft fragment was reported to measure 15 mm in length.The specimen consisted of light tan to brown tissue intermixed with multiple removable rings.The graft material is not visible within the images provided.The rings are largely disrupted, and multiple evenly spaced serration marks are visible.One end has what appear to be two suture throws present within light tan tissue.No luminal aspect is visible within the specimen; thus, determination of patency cannot be made.Material disruptions (e.G., transections, serration marks, ring manipulation) were highly consistent with those caused by surgical instrumentation (e.G., scalpel, scissors) during the explant process.Determination of any material disruptions being present in vivo could not be made based on the information provided.H6-code 10 replaced by 4112: reason: the explanting physician sent the device to a third party for evaluation.The third party provided an explant report which was reviewed and evaluated by gore.
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