BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2575126 · Received May 9, 2012

    Report

    Report Number
    2017233-2012-00303
    Event Type
    Death
    Date Received
    May 9, 2012
    Date of Event
    April 19, 2012
    Report Date
    April 19, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECS. NO FURTHER INFO IS AVAILABLE REGARDING THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE DEVICES WERE DEPLOYED AS PLANNED, AND THE DELIVERY CATHETER AND SHEATH WERE REMOVED WITHOUT INCIDENT. A FINAL ANGIOGRAPH REVEALED A POSSIBLE ENDOLEAK (TYPE AND LOCATION UNK). IT WAS REPORTED THE PT THEN SUDDENLY STOPPED BREATHING. THERE WAS NO EXCESSIVE BLOOD LOSS, OR SIGN OF ANY OTHER EMERGENT PROCESS. ATTEMPTS TO RESUSCITATE WERE UNSUCCESSFUL, AND THE PT EXPIRED. THE PHYSICIAN BELIEVES CAUSE OF DEATH TO BE RESPIRATORY ARREST SECONDARY TO CHRONIC OBSTRUCTIVE PULMONARY DISEASE, AND METABOLIC ACIDOSIS.

    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 9967772

    Patients

    Seq Age Sex Outcome Treatment
    1 Death