BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM

    MDR report key: 2963889 · Received February 15, 2013

    Report

    Report Number
    2953200-2013-00256
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 22, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (ARTERIAL TRAUMA/ DISSECTION/PERFORATION, NEUROLOGIC COMPLICATION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (NARROW VASCULATURE); CAUSED BY ANOTHER DRUG/DEVICE (CONDUIT REMOVAL). CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (NARROW VASCULATURE); ANOTHER DEVICE CAUSED FAILURE (CONDUIT REMOVAL).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED EMERGENTLY IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM APPROXIMATELY TWO MONTHS AGO. THE PATIENT HAD A NARROW VASCULATURE. IT WAS REPORTED THAT THE STENT GRAFTS WERE SUCCESSFULLY IMPLANTED VIA A CONDUIT FOR ACCESS. DURING REMOVAL OF THE CONDUIT AND CLOSURE OF THE ARTERY THE PHYSICIAN BELIEVES AN INTIMAL FLAP WAS CREATED. THE PATIENT LOST FLOW TO THE LEFT LEG LATER THAT NIGHT. THE FOLLOWING DAY THE PHYSICIAN REPAIRED THE INTIMAL FLAP ARE RESTORED BLOOD FLOW TO THE LEG. THE PATIENT HAD SHORT TERM NEUROPATHY, BUT WAS THEN RELEASED HOME AND IS FINE AND WALKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69209 VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01696035

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention