BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA - CW

    MDR report key: 2832902 · Received November 14, 2012

    Report

    Report Number
    2953200-2012-02194
    Event Type
    Death
    Date Received
    November 14, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH, PARALYSIS, PULMONARY EMBOLISM, INACCURATE PLACEMENT); INCORRECT TECHNIQUE/PROCEDURE (INCORRECT DEPLOYMENT PROCEDURE, INSUFFICIENT DEVICE OVERLAP). CONCLUSION: OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (INCORRECT DEPLOYMENT PROCEDURE, INSUFFICIENT DEVICE OVERLAP).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. DURING THE DELIVERY OF THE PROXIMAL STENT GRAFT THE DEVICE WAS RELEASED PRIOR TO COMPLETE DEPLOYMENT AND THE STENT GRAFT MOVED DISTALLY. AN ADDITIONAL PROXIMAL STENT GRAFT WAS IMPLANTED AT THE INITIAL INTENDED LANDING ZONE. IT WAS ALSO REPORTED THAT THE OVERLAP BETWEEN THE SECOND (B)(4) AND THIRD PIECE (B)(4) THERE WAS INADEQUATE OVERLAP AND WAS IN AN UNSUPPORTED SEGMENT OF THE AORTA. AN ADDITIONAL PIECE (B)(4) WAS IMPLANTED BETWEEN THE DEVICES TO ENSURE ADEQUATE OVERLAP. THE CASE WAS COMPLETED. LATER THAT DAY THE PATIENT AWOKE AND WAS UNABLE TO MOVE THEIR LEGS. THE PHYSICIAN IMMEDIATELY PLACED A SPINAL DRAIN. IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO A PULMONARY EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIANT CAPTIVIA - CW SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01140283

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Death