BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT

    MDR report key: 3123092 · Received May 21, 2013

    Report

    Report Number
    2953200-2013-00941
    Event Type
    Death
    Date Received
    May 21, 2013
    Date of Event
    November 9, 2012
    Report Date
    April 25, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: PARALYSIS, DEATH. PRE-OPERATIVE DISSECTION. NOT COMPLETELY EXCLUDING THE ANEURYSM. CONCLUSIONS: PARALYSIS, DEATH. PRE-OPERATIVE RUPTURE. NOT COMPLETELY EXCLUDING THE ANEURYSM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A CHRONIC DESCENDING THORACIC DISSECTION UNDER PHYSICIAN-SPONSORED IDE # (B)(4). THE ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. A LUMBAR DRAIN WAS PLACED IN ORDER TO MINIMIZE THE RISK OF SPINAL ISCHEMIA. THE SUBJECT TOLERATED THE PROCEDURE WELL AND IMPROVED RAPIDLY OVER THE FIRST 24 HOURS. BY THE SECOND EVENING, THE DRAIN WAS CLAMPED WITH NO SYMPTOMS AND THE SPINAL DRAIN WAS REMOVED. LATER IN THE EVENING, THE SUBJECT WAS OUT OF BED AND AMBULATING AND SENSED WEAKNESS IN THE LOWER EXTREMITIES. THE NEUROLOGIC EXAM IN THE LOWER EXTREMITIES DEGENERATED TO WHERE THE SUBJECT HAD LIMITED MOTION IN THE TOES, AND A LUMBAR DRAIN WAS RE-INSERTED. OVER THE ENSUING SEVERAL DAYS THE BILATERAL LOWER EXTREMITY WEAKNESS IMPROVED AND FOLLOWING EVALUATION BY PHYSICAL THERAPY, OCCUPATIONAL THERAPY AND THE NEUROLOGY SERVICE, THE SUBJECT WAS DISCHARGED TO A REHABILITATION FACILITY. ONE WEEK LATER THE PHYSICIAN WAS NOTIFIED BY THE SUBJECT¿S FAMILY THAT THE SUBJECT HAD SUDDENLY DIED THE PREVIOUS EVENING FOLLOWING MEDICATION FOR INSOMNIA. THE SUBJECT WAS FOUND NON-RESPONSIVE AND WAS UNABLE TO BE RESUSCITATED. AN AUTOPSY WAS PERFORMED, AND THE APPARENT CAUSE OF DEATH WAS RUPTURE OF THE DESCENDING THORACIC AORTA JUST ABOVE THE VISCERAL SEGMENT. THE ORIGINAL ENDOGRAFT HAD COVERED THE THORACIC AORTA FROM JUST DISTAL TO THE SUBCLAVIAN ARTERY TO ABOVE THE VISCERAL ARTERIES WITH THE REMAINING INFRARENAL SEGMENT MODERATELY ENLARGED AND WITH A KNOWN RISK OF POTENTIAL RUPTURE IN THE FUTURE WHICH WOULD POTENTIALLY REQUIRE FURTHER INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224859 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Death| R