W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL
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Catalog Number BXA075902A |
Device Problem
Separation Problem (4043)
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Patient Problem
Aneurysm (1708)
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Event Date 07/28/2023 |
Event Type
Injury
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Event Description
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The following information was reported to gore: on (b)(6) 2023, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was intended for use as a branch device in the celiac artery during treatment of an aortic aneurysm.The physician gained access from the arm with a cook medical rosen guide wire.A zenith® t-branch¿ thoracoabdominal endovascular graft was placed on an unknown date to treat the aortic aneurysm.During the deployment of the vbx device, the physician was unable to get a good seal due to the alignment of the zenith® t-branch¿ thoracoabdominal endovascular graft and vbx device into the artery.With the inability to align the zenith® t-branch¿ thoracoabdominal endovascular graft and vbx device properly, it created a separation of the bridging stent graft and the main body t-branch (type iii endoleak).A reintervention was performed on (b)(6) 2023, to reline the vbx device.
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Manufacturer Narrative
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Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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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Section h6 updated to reflect completion of investigation.A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.The device remains implanted and was, therefore, not available for analysis.No clinical images enabling direct assessment of product performance were returned for evaluation.Cause of the reported event cannot be established based on the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.
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