BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2800348 · Received October 16, 2012

    Report

    Report Number
    2953161-2012-00183
    Event Type
    Death
    Date Received
    October 16, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 20, 2012
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE ADDITIONAL DEVICES IMPLANTED: (B)(4). 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, THE PATIENT WAS TREATED WITH GORE EXCLUDER AAA ENDOPROSTHESES FOR AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2012, THE PATIENT PRESENTED TO THE HOSPITAL WITH ABDOMINAL PAIN AND SUDDEN GROWTH OF A PREVIOUS AAA REPAIR WITH A SMALL DISTAL TYPE I ENDOLEAK FROM THE RIGHT LIMB WHERE THE CONTRALATERAL LEG COMPONENT WAS IMPLANTED. THE ANEURYSM SAC SIZE HAD INCREASE TO 8 CM. THE PATIENT HAD TWO POSITIVE BLOOD CULTURES AND A SUDDEN CARDIOVASCULAR DECOMPENSATION. THE PATIENT WAS IMPLANTED WITH A CONTRALATERAL LEG COMPONENT ON THE RIGHT SIDE AND THE ENDOLEAK WAS RESOLVED. A PROXIMAL TYPE I ENDOLEAK WAS IDENTIFIED INTRAOPERATIVELY. AN AORTIC EXTENDER COMPONENT WAS IMPLANTED AND THE ENDOLEAK WAS RESOLVED. THE PHYSICIAN THEN OPENED THE PATIENT'S ABDOMEN TO RELIEVE THE COMPARTMENT SYNDROME. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND THE PATIENT EXPIRED. DR (B)(6) STATED SHE BELIEVES THE PREVIOUSLY PLACED EXCLUDER GRAFT BECAME INFECTED RESULTING IN AN ACUTE GROWTH IN HIS PREVIOUSLY REPAIRED AAA CAUSING THE TYPE IB AND SUBSEQUENT TYPE IA LEAK AND FRANK RUPTURE AND DEATH.

    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 06584038

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death TRAMADOL| CITALOPRAM| SIMVASTATIN| ALLOPURINOL| BACTRIM DS| TIOTROPIUM| TERAZOSIN| SILDENAFIL| PHENAZOPYRIDINE| MOMETASONE FUROATE| HYDROXYZINE| HYDROCORTISONE| HYDOCORTISONE/APAP| FOLIC ACID| CLOPIDOGREL| ALBUTEROL| THIAMINE-100| METHOCARBANOL| QUETIAPINE FUMARTE