BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3143207 · Received May 30, 2013

    Report

    Report Number
    2017233-2013-00346
    Event Type
    Death
    Date Received
    May 30, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE ROOT CAUSE OF THE RUPTURE IS UNK.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED TWO GORE EXCLUDER AAA ENDOPROSTHESES WERE IMPLANTED WITH NO ISSUE. IT WAS REPORTED THAT DURING BALLOONING OF THE PROXIMAL NECK OF THE TRUNK, THE AORTA AT THE LEVEL OF THE RENAL ARTERIES RUPTURED. IT WAS ALSO REPORTED THE SUPERIOR MESENTERIC ARTERY AND PANCREAS APPEARED "SHREDDED" AFTER BALLOONING, BUT IT IS UNK WHAT CAUSED THIS ISSUE. IT WAS REPORTED THE BALLOON WAS NOT OVERINFLATED OR ADVANCED OUTSIDE OF THE GRAFT DURING BALLOONING. AN ATTEMPT WAS MADE TO IMPLANT AN AORTIC EXTENDER COMPONENT TO COVER THE TEAR, BUT IT WAS REPORTED THE PT WAS NOT INTUBATED AND DEPLOYMENT COULD NOT BE PERFORMED. THE DEVICE WAS REMOVED FROM THE PT, AND INTUBATION WAS PERFORMED. AFTER THE PT LOST BLOOD PRESSURE AND WENT INTO CARDIAC ARREST, A DECISION WAS MADE TO CONVERT THE PT TO OPEN REPAIR. IT WAS REPORTEDLY NOTED DURING THE CONVERSATION THE TRUNK HAD NOT PUNCTURED THE PROXIMAL NECK, AND THERE APPEARED TO BE SOME ATHEROSCLEROTIC PLAQUE AT THE LEVEL OF THE RENAL ARTERIES. HOWEVER, THE EXACT CAUSE OF THE RUPTURE IS REPORTEDLY UNK. IT WAS REPORTED THE PHYSICIAN WAS UNABLE TO GAIN CONTROL OF THE BLEEDING DURING THE CONVERSION, AND THE PT EXPIRED DURING THE PROCEDURE DUE TO EXSANGUINATION FROM THE RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239249 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 10837422

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death