W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; PRL / ILIAC COVERED STENT, ARTERIAL
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Catalog Number BXA067902E |
Device Problem
Migration (4003)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/23/2024 |
Event Type
Injury
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Manufacturer Narrative
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A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.C1: cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H3: code "other" was selected as the medical device remains implanted.Return not possible.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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It was reported to gore, that: reportedly, on february 9, 2024, the doctors wanted a vbx 7 79 for the sma in the bevar branch (8 mm).That one (vbx 7 79) was not ordered but they had a 6 79 (bxa067902e) so they choose that one for the procedure, with the knowledge to oversize it to 8 mm because the native vein diameter was 8 mm.They also did not choose the 8 mm pta but the 7 mm instead.On february 23, 2024, fsa got called for an urgent order of a new vbx because the (bxa067902e) was loose in the native artery.Urgent order was in time for procedure.First, it was managed to position the loose vbx in a place (aorta aneurysm) where no harm could be done to the patient and then, the proper vbx (bxa087902e) device was placed in the sma branch.Result was good after the last angiography.Images/fluoroscopy images have been requested but remain unavailable to us.2203-a other code used to capture migration of device in native artery.
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Search Alerts/Recalls
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