BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1952090 · Received January 4, 2011

    Report

    Report Number
    2017233-2011-00002
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 4, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PLEASE NOTE ADD'L DEVICE IMPLANTED: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT UNDERWENT AN ENDOVASCULAR PROCEDURE WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. AFTER THE TRUNK-IPSILATERAL LEG COMPONENT WAS LANDED; A CONTRALATERAL LEG COMPONENT WAS ADVANCED UP THE RIGHT SIDE TO EXTEND THE IPSILATERAL LEG OF THE TRUNK-IPSILATERAL LEG COMPONENT. THE LEADING EDGE OF THE CONTRALATERAL LEG COMPONENT CAUGHT ON THE DISTAL END OF THE TRUNK-IPSILATERAL LEG COMPONENT AND PUSHED THE TRUNK-IPSILATERAL LEG COMPONENT UP APPROXIMATELY 4 CM TO THE SMA. AT THAT TIME, THE PHYSICIAN CHOSE TO DO AN OPEN CONVERSION TO REPAIR THE ANEURYSM. BOTH DEVICES WERE EXPLANTED AND DISCARDED AT THE FACILITY. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG425 8067698

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R