BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1961395 · Received January 10, 2011

    Report

    Report Number
    2017233-2011-00010
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 10, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO GORE, AND AN EXPLANT EVAL IS BEING CONDUCTED. A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. FURTHER INVESTIGATION IS IN PROCESS. ADD'L GORE EXCLUDER AAA DEVICES RELATED TO THIS EVENT: PXC181000/(B)(4), PXC181400/(B)(4), PXC161000/(B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE PT WAS IMPLANTED WITH FOUR GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PT'S AORTIC DIAMETERS WERE WITHIN GUIDELINES OF THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, HOWEVER, THERE WAS A LOT OF THROMBUS IN THE ANEURYSM SAC, AND THE AORTA AND ILIAC ARTERIES WERE TORTUOUS. THE GORE EXCLUDER AAA TRUNK-IPSILATERAL LEG ENDOPROSTHESIS WAS PLACED WITHOUT INCIDENT, FOLLOWED BY TWO GORE EXCLUDER AAA CONTRALATERAL LEG ENDOPROSTHESES. UPON BALLOONING THE PROXIMAL PORTION OF THE TRUNK-IPSILATERAL LEG USING A GORE TRI-LOBE BALLOON, THE CONTRALATERAL LEG SLIPPED OUTSIDE THE CONTRA-GATE BY ABOUT 1MM. AN ADD'L CONTRALATERAL LEG WAS PLACED TO BRIDGE THE RESULTANT GAP. THE FINAL ANGIOGRAPHIC RUN INDICATED THAT THE TRUNK-IPSILATERAL LEG HAD MIGRATED 1.5-3CM PROXIMALLY AND COVERED THE RENAL ARTERIES. ALTHOUGH THE RENAL ARTERIES APPEARED PATENT, THE DECISION WAS MADE TO CONVERT TO OPEN SURGICAL REPAIR. ALL FOUR DEVICES WERE EXPLANTED. THE PT TOLERATED THE PROCEDURE WELL.

    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 8040617

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R