W. L. GORE & ASSOCIATES, INC. GORE® PROPATEN® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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Catalog Number IRTH068080 |
Device Problem
Contamination (1120)
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Patient Problem
Bacterial Infection (1735)
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Event Date 09/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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Device evaluated by manufacturer: the medical device returned to a third party for investigation.The analysis report was shared with gore and evaluated appropriately.The investigation is still ongoing.The results will be included in the final report.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
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Event Description
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It was reported to gore that patient underwent endovascular treatment for a critical ischemia with trophic disorders (deep calcaneal ulcer) with a gore® propaten® vascular graft - thin-walled, integrated rings.It was stated that the prosthesis was implanted on (b)(6) 2015 as a femoro-tibio-peroneal trunk bypass.It was reported that the patient presented several septic episodes and liquid was observed around the bypass.On (b)(6) 2020, after about 5 years, prosthesis was therefore explanted due to the suspicion of infection and a new bypass was performed.It was stated that bacterial cultures performed on a short segment of the prosthetic segment identified to pseudomonas aeruginosa species.
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Manufacturer Narrative
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Product history review: a review of the manufacturing records indicated the lot met all pre-release specifications. a review of the sterilization records indicated the lot met all pre-release specifications.Explant investigation (ei): the following is a summary of the ei observations of the gore® propaten® vascular graft.Tissue present: yes.The device fragment was generally devoid of tissue.The fragment was encased by a large tissue mass (mix of native vessel/tissue; dark brown, tan, and yellow in appearance) at extremity a.The fragment could not be observed inside of the mass of tissue at extremity a.The tissue extremity was occluded by tan/white tissue with some blue running suture being visible.Extremity b was transected and ovular in shape with a blue suture ligaturing the extremity.The luminal patency could not be determined with the information provided.Material disruptions (i.E.Transections, blue suture) are consistent with those caused by surgical instrumentation (i.E., scalpel/scissors, suturing), likely used during a surgical procedure.Request for additional analysis: no.Reason: based on the ei¿s review of the third party report and reason for removal (infection), no additional analysis is requested.
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Manufacturer Narrative
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After consultation with the physician it was revealed that the patient has a history of pre-existing infection in the field of treatment, therefore this incident no longer meets the criteria of a reportable serious incident, and is considered non-reportable.The report is retracted.
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Search Alerts/Recalls
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