BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT CAPTIVIA - FF

    MDR report key: 9218472 · Received October 22, 2019

    Report

    Report Number
    9612164-2019-04463
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Date of Event
    October 16, 2019
    Report Date
    January 20, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY TWISTING WAS OBSERVED ON THE GRAFT COVER 21.8 ¿ 23.8CM FROM THE TIP. THE TAPER TIP WAS SLIGHTLY CURVED. THERE WAS NO FURTHER DAMAGE OBSERVED TO THE DEVICE. THE REPORTED POSITIONING DIFFICULTIES WERE CONFIRMED THROUGH ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH CONFIRMED THAT THE BEND NOTED ON THE DELIVERY SYSTEM ((B)(4)) WAS NOT PRESENT BEFORE THE DEVICE WAS INSERTED INTO THE PATIENT. THE DELIVERY SYSTEM BECAME KINKED DUE TO THE PATIENT'S TORTUOUS ANATOMY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC DISSECTION.   IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE FIRST VALIANT CAPTIVIA DEVICE (VAMF3636C200TE), BUT IT WOULD NOT OPEN DUE TO THE ACUTE ANGLE OF THE AORTA AND COULD NOT BE DEPLOYED. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY A SECOND VALIANT CAPTIVIA (VAMF3434C200TE), HOWEVER IT COULD NOT CROSS THE AORTIC ARCH OVER A LQ WIRE. THE DELIVERY SYSTEM WAS ALSO NOTED TO HAVE BEEN BENT DURING THE ATTEMPTED DELIVERY. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED, DUE TO THE TORTUOUS PATIENT ANATOMY AND SMALL TRUE LUMEN. THE PATIENT HAD A COMPLEX TYPE B DISSECTION WITH ANGULATED ANATOMY.   NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013704 VALIANT CAPTIVIA - FF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND VAMF3434C200TE

    Patients

    Seq Age Sex Outcome Treatment
    1