BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT XCELERANT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1563940 · Received December 21, 2009

    Report

    Report Number
    2953200-2009-01855
    Event Type
    Death
    Date Received
    December 21, 2009
    Date of Event
    November 20, 2009
    Report Date
    November 25, 2009
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS, CONCLUSION: DEATH. CARDIAC DISEASE, DEATH WAS RELATED TO A CARDIAC EVENT. EVALUATION OF THE EXPLANTED STENT GRAFT IS PENDING.

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. THE THORACIC AORTA WAS UNREMARKABLE; HOWEVER, THE PT HAD KNOWN CARDIAC DISEASE. IT WAS REPORTED THAT THE STENT GRAFT WAS SUCCESSFULLY IMPLANTED WITHOUT COMPLICATIONS; HOWEVER, 24-48 HOURS POST IMPLANT, THE PT WAS PARALYZED. IT WAS NOTED THAT A SPINAL DRAIN WAS NOT USED IN THIS PROCEDURE. AFTER A FEW DAYS, THE PT DIED OF A CARDIAC EVENT AND THE STENT GRAFT WAS EXPLANTED AT AUTOPSY IN 2009. THE EXPLANTED STENT GRAFT WAS RECEIVED AND ITS EVALUATION IS PENDING. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT XCELERANT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00195872

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death