W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/23/2023 |
Event Type
malfunction
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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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The following article was reviewed: squizzato, f., antonello, m., grego, f.And piazza, m., 2023.Use of intravascular ultrasound for the technical assessment of covered endovascular reconstruction of the aortic bifurcation.Journal of vascular surgery, 77(6), pp.E75-e76.Https://doi.Org/10.1016/j.Jvs.2023.03.084.This was a single-center, retrospective review of 44 patients undergoing endovascular treatment of severe aorto-iliac obstructive disease (2019-2022).Only patients treated with the covered endovascular reconstruction of the aortic bifurcation (cerab) technique were included.Aortic coverage was obtained with deployment of a viabahn vbx balloon expandable stent.Two kissing balloon-expandable stents were used for the completion of cerab, and postdilatation was systematically performed.Intravascular ultrasound detected a significant unilateral stent compression in eight kissing stents, that were successfully treated with re-ballooning and eventual additional stenting.
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Search Alerts/Recalls
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