BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1561322 · Received December 16, 2009

    Report

    Report Number
    2953200-2009-01807
    Event Type
    Death
    Date Received
    December 16, 2009
    Date of Event
    November 18, 2009
    Report Date
    November 18, 2009
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: (DEATH). (UNSTABLE CONDITION AND ALREADY RECEIVING CHEST COMPRESSIONS/CPR PRIOR TO THE ENDOVASCULAR PROCEDURE). (PREVIOUSLY IMPLANTED CONVENTIONAL GRAFT WAS LEAKING).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE EMERGENT ENDOVASCULAR REPAIR OF A PREVIOUSLY IMPLANTED CONVENTIONAL GRAFT THAT WAS FOUND TO BE LEAKING BELOW THE LEVEL OF THE RENAL ARTERIES. THE AORTIC NECK WAS LESS THAN 10 MM IN LENGTH AND THE DIAMETER AT THE RENAL ARTERIES WAS REPORTED AS 31 MM. SINCE THIS WAS A TUBE GRAFT, THE SIZE WAS THE SAME GOING DOWN. THE CONVENTIONAL GRAFT THAT WAS PREVIOUSLY SEWN IN THE PT ON AN UNK DATE WAS FOUND TO BE LEAKING. THE PT WAS THEN TRANSFERRED TO ANOTHER HOSPITAL SINCE THE FACILITY THEY WERE AT DID NOT HAVE THE CAPABILITY FOR ENDOVASCULAR REPAIR. THE PT WAS UNSTABLE WHEN THE PHYSICIAN IMPLANTED TWO TALENT AORTIC CUFFS TO REPAIR THE LEAK THAT WAS COMING FROM THE CONVENTIONAL GRAFT. DURING THE IMPLANTATION OF THE TALENT CUFFS THE PT WAS RECEIVING CHEST COMPRESSIONS/CPR. THE TWO TALENT STENT GRAFTS WERE IMPLANTED AND APPEARED TO SUCCESSFULLY RESOLVE THE ENDOLEAK. THE PHYSICIAN ELECTED TO MODEL THE CUFFS WITH A RELIANT BALLOON AND THE BALLOON WAS REMOVED FROM THE PT. THE PT WAS THEN "SHOCKED" WITH PADDLES TO RESTART THE PT'S HEART. THE PT CONTINUED TO GET CHEST COMPRESSION; HOWEVER, AFTER 10 MINUTES, THE PHYSICIAN STOPPED THE CHEST COMPRESSION AND THE PT EXPIRED. NO ADDITIONAL INFO WAS PROVIDED. SEE MFR# 2953200-2009-01806.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00237167

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death