BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HYBRID VASCULAR GRAFT

    MDR report key: 3192482 · Received June 14, 2013

    Report

    Report Number
    2017233-2013-00372
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    December 29, 2012
    Report Date
    May 20, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K093934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGING PROVIDED DOES NOT ALLOW FOR EVAL IN RELATIONSHIP TO THIS EVENT.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED TO GORE AN OCCLUSION WITH THE USE OF A GORE HYBRID VASCULAR GRAFT USED IN A LOWER LIMB CASE. THE GORE HYBRID VASCULAR GRAFT WAS EXPLANTED 21 DAYS POST IMPLANT. ACCORDING TO THE PHYSICIAN, THE GORE HYBRID VASCULAR GRAFT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT, AND, THE PT WAS AT RISK FOR CRITICAL LIMB ISCHEMIA (CLI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272163 GORE HYBRID VASCULAR GRAFT DSY / PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention