BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 3073423 · Received April 23, 2013

    Report

    Report Number
    2953200-2013-00759
    Event Type
    Death
    Date Received
    April 23, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (VESSEL OCCLUSION, DEATH); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-EXISTING CONDITION; PRE-OP OCCLUDED CELIAC ARTERY); CAUSED BY ANOTHER DRUG/DEVICE (OTHER MANUFACTURER'S SMA STENT). CONCLUSION: DEVICE FAILURE RELATED TO PATIENT CONDITION (PRE-EXISTING CONDITION; PRE-OP OCCLUDED CELIAC ARTERY); ANOTHER DEVICE CAUSED FAILURE (OTHER MANUFACTURER'S SMA STENT).

    Description of Event or Problem · 1

    A VALIANT THORACIC STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM. VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN DETERMINED THE CELIAC ARTERY WAS OCCLUDED AND INTENTIONALLY COVERED IT DEPLOYING THE STENT GRAFT DOWN TO THE SMA. THE SECOND STENT GRAFT WAS IMPLANTED TO EXTEND THE STENT GRAFT AND IT WAS PLACED IMMEDIATELY AFTER THE FIRST GRAFT WAS PLACED. ON THE FINAL RUN, IT WAS OBSERVED THAT HIS SMA WAS ALSO OCCLUDED. THERE WAS THROMBUS OBSERVED IN THE SMA, THE STENT GRAFT WAS NOT COVERING THE SMA AND THE STENT GRAFT WAS POSITIONED AS INTENDED. AFTER SEVERAL ATTEMPTS, A BARE METAL STENT WAS DELIVERED AND DEPLOYED INTO THE SMA LEAVING IT OPEN AND THE CASE ENDED. THE FOLLOWING DAY THE PATIENT WENT INTO LIVER FAILURE AND EXPIRED. THE PHYSICIAN NOTED CONTRAST/BLOOD IN THE HEPATIC ON CT SCAN AND IT IS THOUGHT THAT THE HEPATIC VEIN MAY HAVE THROMBOSED CAUSING PATIENT DEATH. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173653 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03019716

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Death