W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL
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Catalog Number BXA072902E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Obstruction/Occlusion (2422)
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Event Date 05/23/2022 |
Event Type
Death
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Event Description
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Reportedly on (b)(6) 2020, this patient underwent an endovascular repair of a thoracoabdominal aneurysm, which was treated with a fenestrated and branched stent graft component (zenith® t-branch® thoracoabdominal endovascular graft, cook medical).During the procedure planning, it was determined that the superior mesenteric artery, right and left renal artery will be incorporated in the fenestrated and branched endograft.Three gore® viabahn® vbx balloon expandable endoprostheses (viabahn® vbx device) were implanted in the superior mesenteric artery, right and left renal artery.Reportedly, the whole procedure was uneventful, aortic access was successfully gained, device deployed as intended, catheters were successfully removed and the patency of the devices were confirmed at the end of the procedure.The patient received an additional antiplatelet medication during the procedure.According to reports, on (b)(6) 2022 during a follow-up visit, a cta was performed and an adverse event termed "superior mesenteric artery stent occlusion" was discovered.The relationship was recorded as device related.
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Manufacturer Narrative
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No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Code b13: further information related to the procedure, the incident and the patient condition was requested from the hospital and will be captured in the final report once provided.Code b20: the device remains implanted in the patient.Therefore a device evaluation could not be performed.Review of the manufacturing records indicated the device met pre-release specifications.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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H1: corrected type of reportable event.
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Search Alerts/Recalls
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