W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Model Number RLT261412 |
Device Problem
Material Invagination (1336)
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Patient Problem
Aneurysm (1708)
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Event Date 03/06/2023 |
Event Type
Injury
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Event Description
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On (b)(6) 2023, this patient underwent treatment for abdominal aortic aneurysm and a unilateral common iliac artery aneurysm (ciaa) and was implanted with gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses (ibe).The patient tolerated the procedure.On (b)(6) 2023, the physician reported that the patient underwent reintervention on (b)(6) 2023 due to infolding of the trunk ipsilateral leg component and the proximal bridge graft ((b)(4)) to the iliac branch component.It was reported that an axillo-bifemoral bypass was performed.No explant of any of the devices was reported.The patient tolerated the procedure.A cause of the infolding was not provided.
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Manufacturer Narrative
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The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis and gore® excluder® iliac branch endoprostheses states; adverse events that may occur and / or require intervention include but are not limited to: endoprosthesis: component migration; occlusion w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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The imaging evaluation performed by a clinical imaging specialist showed the following: ¿ two movies provided for evaluation, one 34 second video (b)(6), pages 2-3 and one 23 second video (b)(6), page 4 with screen captures of still images are below.Images cannot be manipulated in anyway.The observed crescent-shaped appearance of the device is consistent with device compression.Occlusion of the graft is also visualized.
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Manufacturer Narrative
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The device evaluation was performed based on an event description as reported to gore, and images attached to smartsolve as the device was not returned for analysis.The observed crescent-shaped appearance of the device is consistent with device compression.Occlusion of the graft is also visualized.Based on the imaging evaluation and without a physical sample to evaluate, the physician¿s observation of ¿infolding of the trunk ipsilateral leg component and the proximal bridge graft¿ is consistent with device compression.The likely cause for the physician¿s observation of ¿infolding of the trunk ipsilateral and the proximal bridge graft¿ could not be determined from the information provided.
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