BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 1241085 · Received November 21, 2008

    Report

    Report Number
    2017233-2008-00897
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 21, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    IN 2008, A FEMALE WAS IMPLANTED WITH A GORE PROPATEN VASCULAR GRAFT IN A COMMON FEMORAL ARTERY TO ANTERIOR TIBIAL ARTERY PROCEDURE IN THE RIGHT LEG. THE FOLLOWING MONTH, IT WAS REPORTED THAT THE PATIENT PRESENTED WITH COMPLAINTS OF COLD, CRAMPING AND REST PAIN SENSATION IN THE RIGHT LEG. PATIENT WAS ADMITTED TO THE HOSPITAL. TWO DAYS LATER, A RIGHT LOWER EXTREMITY BYPASS WAS PERFORMED WITH A GRAFT REPLACEMENT DUE TO THE GRAFT BEING OCCLUDED. AN ESOPHAGEAL TEAR OCCURRED DURING INTUBATION FOR THE REVISION PROCEDURE. PATIENT HAD ESOPHOGRAM PERFORMED FOUR DAYS LATER, WITH NO EVIDENCE OF INJURY. A BRONCHOSCOPY AND AN ESOPHAGOGASTRODUODENOSCOPY WAS PERFORMED ON THE SAME DAY, WITH A LINEAR TEAR NOTED, WITHOUT EVIDENCE OF A PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE PROPATEN VASCULAR GRAFT NONE DSY W.L. GORE & ASSOCIATES WLG450 2183605PP026

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention