BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT XCELERANT STENT GRAFT

    MDR report key: 2170031 · Received July 15, 2011

    Report

    Report Number
    2953200-2011-01286
    Event Type
    Death
    Date Received
    July 15, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 15, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: (DEATH). RESULTS/CONCLUSIONS: (DISSEMINATED INTRAVASCULAR COAGULOPATHY).

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM 54 MONTHS AGO. VESSEL MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT THE PT PRESENTED WITH ABDOMINAL PAIN SYNDROME ONE MONTH AGO. A CT SCAN WAS TAKEN AND REVEALED THAT THERE WAS A TYPE III ENDOLEAK, FABRIC TEAR, COMING FROM THE STENT GRAFT BODY. THE SURGEON ATTEMPTED TO TREAT THE ENDOLEAK THROUGH AN ENDOVASCULAR APPROACH BUT THE ANEURYSM RUPTURED. THE SURGEON THEN TRIED A LAPAROTOMY; HOWEVER, THE PT SUFFERED FROM DISSEMINATED INTRAVASCULAR COAGULOPATHY AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT XCELERANT STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR NA 1000007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death