BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1972259 · Received January 20, 2011

    Report

    Report Number
    2953161-2011-00016
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    March 10, 2010
    Report Date
    January 20, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2009, THIS PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND LARGE LEFT AND RIGHT INTERNAL ILIAC ARTERY ANEURYSMS. A GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT WAS IMPLANTED WITH A CONTRALATERAL LEG COMPONENT IMPLANTED FOR EXTENSION ON THE RIGHT. INTRA-OPERATIVE ANGIOGRAPHY REPORTEDLY IDENTIFIED A DISTAL TYPE I ENDOLEAK ON THE PATIENT'S RIGHT SIDE, SO AN ILIAC EXTENDER COMPONENT WAS IMPLANTED FOR DISTAL EXTENSION. FINAL ANGIOGRAPHY SHOWED NO EVIDENCE OF ENDOLEAK, AND THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN TAKEN ON AN UNKNOWN DATE SHOWED A POSSIBLE DISTAL TYPE I ENDOLEAK FROM THE LEFT COMMON ILIAC ARTERY. ON (B)(6) 2010, THE PATIENT WAS BROUGHT TO THE CATHETER LAB FOR AN ANGIOGRAM. IT WAS REPORTED THAT A SMALL TYPE I ENDOLEAK WAS AGAIN SEEN ON ANGIOGRAPHY, SO THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL CONTRALATERAL LEG COMPONENT IN THE LEFT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, A FOLLOW-UP CT SHOWED RESOLUTION OF THE LEFT DISTAL TYPE I ENDOLEAK.

    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, INC. WLG325 06718541

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R