BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2010448 · Received March 4, 2011

    Report

    Report Number
    2953200-2011-00596
    Event Type
    Death
    Date Received
    March 4, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (DEATH). EVALUATION, RESULTS/CONCLUSIONS: (DISSECTION). (USE OF THE DEVICE TO TREAT A DISSECTION).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF AN ACUTE B TYPE DISSECTION. THE PT HAD A HISTORY OF VALVE AND ASCENDING AORTA REPLACEMENT. IT WAS REPORTED THAT ANOTHER MANUFACTURER'S STENT GRAFT WAS IMPLANTED FIRST, FOLLOWED BY IMPLANTING A TALENT STENT GRAFT PROXIMALLY, WHICH COVERED THE LEFT SUBCLAVIAN ARTERY. THE IMPLANTATION WAS SUCCESSFUL; HOWEVER, AFTER IMPLANTATION, THE PATIENT'S BLOOD PRESSURE DROPPED TO 30 MM HG, AS THE PT HAD A RUPTURED ABDOMINAL AORTIC ANEURYSM; THE PT EXPIRED. THE PHYSICIAN COMMENTED THAT THE EVENT WAS NOT RELATED TO THE TALENT STENT GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00541194

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death