W. L. GORE & ASSOCIATES, INC. GORE® DRYSEAL FLEX INTRODUCER SHEATH; INTRODUCER, CATHETER
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Model Number DSF2433 |
Device Problems
Malposition of Device (2616); Patient-Device Incompatibility (2682)
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Patient Problem
Vascular Dissection (3160)
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Event Date 09/27/2022 |
Event Type
Injury
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Event Description
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On (b)(6) 2022, this patient underwent endovascular treatment of a thoracic aorta aneurysm.A gore® dryseal flex introducer sheath was used for access.During the procedure, vessel damage was observed in the right external iliac artery on the angiography.The physician decided to place two stent grafts from common iliac artery down to external iliac artery, and so the right internal iliac artery was covered by the stent graft.A dissection was also observed distally from the puncture site, and it was surgically repaired from the inguinal area.The patient tolerated the procedure.It was reported that the diameter of the right external iliac artery was narrow, approximately 6.5mm.
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Manufacturer Narrative
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Device evaluated by mfr: code "other" was selected as the medical device was discarded at facility.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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H6: codes d1101 and d12 added.It should be noted the gore® dryseal flex introducer sheath instructions for use (ifu) states: ¿adequate vessel access is required to introduce the sheath into the vasculature.Careful evaluation of vessel size, anatomy, tortuosity, and disease state (including calcification, plaque, and thrombus) is required to ensure successful sheath introduction and subsequent withdrawal.If vessel is not adequate for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result.¿ it should be noted that per gore® dryseal flex introducer sheath instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to vascular trauma and dissection.
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Search Alerts/Recalls
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