BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONE

    MDR report key: 3201118 · Received June 27, 2013

    Report

    Report Number
    9680654-2013-00004
    Event Type
    Death
    Date Received
    June 27, 2013
    Date of Event
    April 13, 2013
    Report Date
    June 26, 2013
    Manufacturer
    WILLIAM COOK AUSTRALIA
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC DEVICE MODEL/CATALOGUE NUMBER/LOT NUMBER NOT PROVIDED BY THE REPORTER. BASED ON THE INFORMATION PROVIDED, THE DEVICE IS DETERMINED TO BE A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT. EVAL BASED ON EVENT DESCRIPTION. THERE IS NO EVIDENCE THAT A DEVICE NON-CONFORMANCE OR DEFICIENCY CONTRIBUTED TO THE EVENT. THE CAUSE OF DEATH IS RELATED TO THE PT'S REACTION TO THE ANTICOAGULANT. THE IFU SENT WITH THE DEVICE (IFU-FU) STATES, "SYSTEMIC ANTICOAGULATION SHOULD BE USED DURING THE IMPLANTATION PROCEDURE BASED ON HOSPITAL AND PHYSICIAN PREFERRED PROTOCOL. IF HEPARIN IS CONTRAINDICATED, AN ALTERNATIVE ANTICOAGULANT SHOULD BE CONSIDERED." IN SECTION 11.3 PT PREPARATION, IT STATES, "REFER TO INSTITUTIONAL PROTOCOLS RELATING TO ANESTHESIA, ANTICOAGULATION AND MONITORING OF VITAL SINGS," AND IN SECTION 11.4.5 PROXIMAL BODY PLACEMENT, IT STATES, "NOTE: MONITOR THE PT'S COAGULATION STATUS THROUGHOUT THE PROCEDURE." THE IFU ALSO STATES THAT POTENTIAL ADVERSE EVENTS INCLUDE COAGULOPATHY, ARTERIAL OR VENOUS THROMBOSIS AND/OR PSEUDOANEURYSM, OCCLUSION OF DEVICE OR NATIVE VESSELS, NEUROLOGIC LOCAL OR SYSTEMIC COMPLICATIONS AND SUBSEQUENT ATTENDANT PROBLEMS (E.G. CONFUSION, STROKE, TRANSIENT ISCHEMIC ATTACK, PARAPLEGIA, PARAPARESIS, PARALYSIS) AND DEATH."

    Description of Event or Problem · 1

    A (B)(6) FEMALE UNDERWENT EVAR ON (B)(4) 2013. THE PHYSICIAN PLACED A ZENITH FENESTRATED MAIN BODY GRAFT, A ZENITH FLEX LEG GRAFT WITH SPIRAL-Z TECHNOLOGY AND THREE ZILVER STENTS. UNBEKNOWNST TO THE PHYSICIAN, THE PT HAD HEPARIN-INDUCED THROMBOCYTOPENIA WHICH CLOTTED OFF THE ARTERIES TO THE SPINE RESULTING IN PARALYSIS. THE PT EXPIRED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293961 NONE MIH WILLIAM COOK AUSTRALIA ZENITH FENESTRATED AAA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| H