BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3122501 · Received May 15, 2013

    Report

    Report Number
    2953161-2013-00067
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS- THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICES IMPLANTED AND INVOLVED IN THIS EVENT INCLUDE: PXT281412/04362611, PXC201200/04908858, PXC201400/04901803, PXC201000/04663263, PXA280300/04935063, PXA230300/04479563, PXC121400/10642058 AND PXC121200/10366081.

    Description of Event or Problem · 1

    ON (B)(6) 2007, THE PATIENT WAS IMPLANTED WITH A SIX GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE TWO AORTIC EXTENDER COMPONENTS WERE IMPLANTED BILATERALLY IN THE COMMON ILIAC ARTERIES. ON (B)(6) 2013, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH ABDOMINAL PAIN. CT IMAGES SHOWED AN ENLARGED ABDOMINAL AORTIC ANEURYSM MEASURING 8.4 CM, A DISTAL TYPE I ENDOLEAK ASSOCIATED WITH ONE OF THE AORTIC EXTENDER COMPONENTS, AND A TYPE II ENDOLEAK FROM MULTIPLE ILIO-LUMBAR ARTERIES. IT WAS REPORTED THE PATIENT'S TORTUOUS ILIAC ARTERIES CAUSED A LACK OF SEAL ON THE AORTIC EXTENDER COMPONENT, THEREBY CONTRIBUTING TO THE DISTAL TYPE I ENDOLEAK. THE SAME DAY, A REINTERVENTION WAS PERFORMED TO ADDRESS BOTH ENDOLEAKS. TWO CONTRALATERAL LEG COMPONENTS WERE IMPLANTED DISTALLY ON THE RIGHT SIDE WITH INTENTIONAL COVERAGE OF AN ILIO-LUMBAR ARTERY. FINAL IMAGING SHOWED RESOLUTION OF THE ENDOLEAKS, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215158 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 04479563

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R PREVACID| LOPRESSOR| OXYCODONE| LORAZEPAM| LISINOPRIL| SIMVASTATIN