BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX VASCULAR GRAFT

    MDR report key: 2151578 · Received June 29, 2011

    Report

    Report Number
    2017233-2011-00325
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 28, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K881732
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THE ENGINEERING EVALUATION STATED THAT THE CROSS SECTION OF THE GRAFT NEAREST TO THE RING SECTION IS INDICATIVE OF HAVING BEEN CUT WITH SHEARS. THE OPPOSITE END OF THE GRAFT IS INDICATIVE OF A TEAR AND THE RADIAL REINFORCEMENT FILM IS MISSING FOR APPROXIMATELY 3MM FROM THIS END. THE LONGITUDINAL FILM UNDER THE FIRST TWO RINGS NEAREST THE DISRUPTED SIDE IS LOOSE. THE EXAMINATION FOUND NO ANOMALIES ATTRIBUTABLE TO THE MANUFACTURE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE THAT THE GRAFT RUPTURED 2 CMS FROM THE PROXIMAL ANASTOMOSIS. THE GRAFT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX VASCULAR GRAFT DSY/PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY W.L. GORE & ASSOCIATES WLG401 06823691

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention