W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL
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Device Problem
Complete Blockage (1094)
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Patient Problem
Obstruction/Occlusion (2422)
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Event Date 05/03/2019 |
Event Type
Injury
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Manufacturer Narrative
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Patient identifier: 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.(b)(4).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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Event Description
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Reportedly on (b)(6) 2019, this patient underwent an endovascular repair of a thoracoabdominal aneurysm iii which was treated with a fenestrated and branched stent graft component (zenith® t-branch® thoracoabdominal endovascular graft, cook medical).During the procedure planning, the following aortic branches were selected for treatments: celiac trunk, superior mesenteric artery, right and left renal artery.Four gore® viabahn® vbx balloon expandable endoprostheses (viabahn® vbx device) were implanted in these arteries.Reportedly, the whole procedure was uneventful, aortic access was successfully gained, device navigated and 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.Reportedly, on (b)(6) 2019 an adverse event termed "occlusion right renal artery inside vbx stent" was discovered and it was recorded as device related.According to report, the gore vbx didn't contribute to the adverse event, no medical or surgical intervention was performed, the device wasn't explanted and the renal artery remained permanently occluded.
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