W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY
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Catalog Number JHJR080502J |
Device Problems
Patient-Device Incompatibility (2682); Migration (4003)
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Patient Problem
Pseudoaneurysm (2605)
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Event Date 06/23/2023 |
Event Type
Injury
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Event Description
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On (b)(6) 2020, this patient underwent endovascular treatment for left internal iliac artery pseudoaneurysm using gore® viabahn® endoprosthesis (viabahn).During the procedure, two viabahn devices were implanted in jointed fashion as one unit.On (b)(6) 2023, during follow-up exam, it was discovered that the proximal portion of the implanted viabahns had migrated proximally from its original position.The exam also confirmed a distal type i endoleak which was considered to have occurred due to the migration.The pseudoaneurysm was found to have shrunken.A secondary procedure is being planned to add an additional viabahn, to treat the migration and endoleak.The date of reintervention has not yet been determined.It is unknown which device serial number was implanted on the proximal/distal side.No specific comments were provided from the physician regarding the cause of the event.
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Manufacturer Narrative
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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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Manufacturer Narrative
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Missing ifu for code d12 was added: according to the gore® viabahn® endoprosthesis instructions for use, adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: migration.Two devices of same type (gore® viabahn® endoprosthesis with heparin bioactive surface) were implanted in an overlapped fashion as one unit in the patient¿s hypogastric artery during the same procedure.See manufacturer report # 2017233-2023-04116.Emdr section h6 e code was corrected.
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