BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM

    MDR report key: 3024336 · Received March 27, 2013

    Report

    Report Number
    2953200-2013-00541
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 28, 2013
    Report Date
    April 12, 2013
    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: ARTERIAL DISSECTION. PRE-OPERATIVELY DISSECTED THORACIC AORTA. STENT GRAFT WAS USED FOR TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY DISSECTED THORACIC AORTA. CONCLUSIONS: PRE-OPERATIVELY DISSECTED THORACIC AORTA. STENT GRAFT WAS USED FOR TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY DISSECTED THORACIC AORTA.

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (TORTUOUS ANATOMY). (B)(4).

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION APPROXIMATELY FOUR MONTHS AGO. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH SEVERE BACK PAIN. A CT SCAN WAS DONE AND A NEW TEAR DISTAL TO THE STENT GRAFT WAS DISCOVERED. IT IS LIKELY THAT THE STENT GRAFT MAY HAVE NOT COVERED THE ORIGINAL TEAR DURING THE TIME OF IMPLANT. ONE DAY LATER TWO EXTENSIONS WERE IMPLANT DOWN TO THE LEVEL OF THE CELIAC ARTERY AND SUCCESSFULLY RESOLVED THIS EVENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE STENT GRAFTS THAT WERE USED TO TREAT THE PATIENT WERE A VALIANT (B)(4). THE PATIENT'S ANATOMY WAS VERY TORTUOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125283 VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01089280

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention