W. L. GORE & ASSOCIATES, INC. GORE-TEX® STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT
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Catalog Number ST0701 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hematoma (1884)
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Event Date 03/08/2016 |
Event Type
Injury
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Event Description
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It has been reported to gore that, on (b)(6) 2016, this patient underwent a surgical repair of peripheral arterial disease located in the common femoral artery and was treated with a gore-tex® stretch vascular graft, the patient received heparin as an additional antiplatelet treatment.It was reported that the patient tolerated the procedure, it was also recorded that the procedure was uneventful, the device was implanted and retained, and that the patient was discharged on (b)(6), 2016.On (b)(6) 2016, an adverse event termed "hematoma evacuation of the right scarpa" was reported.It was recorded in the registry that this adverse event is procedure-related, required an intervention/treatment and resolved without sequalae.
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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.H3 code b20 and h6 : the device remains implanted in the patient.Therefore a device evaluation could not be performed.H6 code b14: a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.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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