W. L. GORE & ASSOCIATES, INC. GORE-TEX® STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT
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Catalog Number SRRT06060080L |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problems
Bacterial Infection (1735); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/18/2018 |
Event Type
Injury
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Event Description
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A study alert from the pvg 21-01 clinical study was received: on (b)(6) 2016, the patient underwent treatment for an occlusive peripheral artery disease in which a gore-tex® stretch vascular graft was used as a bypass for a femoro-peroneal procedure.The patient was discharged on (b)(6) 2016.Reportedly, the whole procedure was uneventful, vascular access was successfully gained, device deployed as intended, catheter was successfully removed and the patency of the devices were confirmed at the end of the procedure.The patient received an additional antiplatelet medication during the procedure.Reportedly on (b)(6) 2018 a graft infection was discovered, this was a recorded as device-related.An unspecified reintervention was administered and the patient required without a sequelae.
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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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Manufacturer Narrative
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Emdr section h6 codes updated to reflect results of investigation.
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Search Alerts/Recalls
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