BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT (STRETCH SMALL DIAMETER)

    MDR report key: 1132126 · Received August 21, 2008

    Report

    Report Number
    2017233-2008-00502
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    June 2, 2006
    Report Date
    August 21, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING AND STERILIZATION PAPERWORK HAS BEEN CONDUCTED. RESULTS -THE REVIEW OF THE MANUFACTURING AND STERILIZATION PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED FROM ANOTHER COUNTRY: "A FEMOROPOPLITEAL BYPASS (P I, AK) WAS PERFORMED WITH A GORE PROPATEN VASCULAR GRAFT IN THE PATIENT BECAUSE OF AN ARTERIAL OCCLUSION IN THE THIGH. AN INFECTION (OR ALLERGIC REACTION) OCCURRED IN THE GROIN AND THE GRAFT ALSO RUPTURED AT THE DISTAL ANASTOMOSIS. A PART OF THE GRAFT WAS EXPLANTED (PART OF THE GRAFT WAS LEFT IN PLACE). TWO OTHER BYPASSES WERE THEN MADE, ONE WITH GORE PROPATEN VASCULAR GRAFT AND ONE WITH AUTOLOGOUS VEIN. BOTH FAILED. IN ANOTHER HOSPITAL ANOTHER VEIN BYPASS WAS THEN DONE. WE ONLY GOT TO KNOW ABOUT THIS EVENT THIS WEEK AS A LAWYER IS NOW TRYING TO SUE THE SURGEON BECAUSE OF THE GROIN INFECTION OR AS HE CLAIMS "ALLERGIC REACTION". THE LAWYER OF THE PATIENT BELIEVES THAT THE ALLERGIC REACTION WAS CAUSED BECAUSE OF THE EPTFE MATERIAL. THE SURGEON DOES NOT THINK THAT THE GRAFT MATERIAL CAUSED THE REACTION AND HAS ASKED FOR SOME DOCUMENTATION WITH REGARDS TO EPTFE AND INFECTIONS/ALLERGIC REACTIONS." FURTHER INVESTIGATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE PROPATEN VASCULAR GRAFT (STRETCH SMALL DIAMETER) NONE DSY W.L. GORE & ASSOCIATES WLG450 1543395PP025

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention