BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT THORACIC STENT GRAFT WITH XCELERANT

    MDR report key: 2162119 · Received July 8, 2011

    Report

    Report Number
    2953200-2011-01265
    Event Type
    Death
    Date Received
    July 8, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 10, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (ENDOLEAK). (INSUFFICIENT, INFO; UNK CAUSE OF ENDOLEAK). EVALUATION, CONCLUSIONS: (INSUFFICIENT INFO; UNK CAUSE OF ENDOLEAK).

    Description of Event or Problem · 1

    A VALIANT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN UNK THORACIC LESION APPROX ONE YEAR AGO. VESSEL MORPHOLOGY WAS REPORTED AS NO CALCIFICATION. IT WAS REPORTED THAT BASED ON A CT SCAN, TAKEN ON AN UNK DATE, THE PHYSICIAN ASSESSED THAT THE PT HAD A PROXIMAL ENDOLEAK, THE EXACT LOCATION UNK. AN OPEN SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE THORACIC AORTA, WITH THE PT ON A HEART-LUNG MACHINE DURING THE OPERATION. AT THE END OF THE OPERATION THE PHYSICIANS COULD NOT GAIN CONTROL OF THE BLOOD COAGULATION. THE PT EXPIRED DUE TO INTERNAL BLEEDING DUE TO THE COAGULATION DIFFICULTIES. AFTER THE EXPLANT, THE PHYSICIAN NOTED TWO HOLES IN THE PROXIMAL PORTION OF THE STENT GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIANT THORACIC STENT GRAFT WITH XCELERANT MIH MEDTRONIC CARDIOVASCULAR IRELAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death