BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HYBRID VASCULAR GRAFT

    MDR report key: 2234038 · Received August 29, 2011

    Report

    Report Number
    2017233-2011-00444
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 29, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K093934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROCESS PENDING THE COMPLETION OF THE HISTOLOGICAL EVAL OF THE RETURNED GRAFT.

    Description of Event or Problem · 1

    A GORE HYBRID VASCULAR GRAFT WAS IMPLANTED IN THE UPPER ARM DURING AN AV DIALYSIS ACCESS PROCEDURE. DURING IMPLANTATION, THE PHYSICIAN REPORTED A LEAK AT TRANSITION OF THE NITINOL REINFORCED SECTION (NRS) AND THE VASCULAR GRAFT SECTION. AN ENDOGRAFT WAS USED TO CREATE A BRIDGE BETWEEN THE GRAFT AND THE NRS BECAUSE OF A PERCEIVED LEAK. THE NRS AND ENDOGRAFT WERE LOCATED AT THE VENOUS END OF THE HYBRID GRAFT. SEVERAL WEEKS POST IMPLANT, THE HYBRID GRAFT CLOTTED AT THE ARTERIAL ANASTOMOSIS CAUSING A 3-4 CM PSEUDOANEURYSM. THE HYBRID GRAFT WAS EXPLANTED. DURING EXPLANT, THE PHYSICIAN SUSPECTED AN INFECTION OF THE HYBRID GRAFT. A PATCH WAS USED TO SEAL THE ANASTOMOSIS. THE PT WAS REPORTED TO BE FINE FOLLOWING THE SURGICAL PROCEDURE. THE USER FACILITY DID NOT PERFORM TEST ON THE GRAFT TO CONFIRM THE SUSPECTED HYBRID GRAFT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE HYBRID VASCULAR GRAFT DSY / PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES WLG417

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention GORE VIABAHN ENDOPROSTHESIS