BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 4771679 · Received May 14, 2015

    Report

    Report Number
    2953200-2015-00882
    Event Type
    Injury
    Date Received
    May 14, 2015
    Date of Event
    April 22, 2015
    Report Date
    May 19, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, CONCLUSION: OFF-LABEL, UNAPPROVED OR CONTRAINDICATED USE (STENT GRAFT WAS IMPLANTED FOR A PRE-OPERATIVE DISSECTION AND IMPLANTED IN ZONE 1).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A TYPE B DISSECTION IN ZONE 1. THE DIAMETER OF THE NON-ANEURYSMAL PROXIMAL NECK WAS 42 MM. ANOTHER MANUFACTURER¿S 36/36/200 STENT GRAFT WAS ALSO IMPLANTED AT THE SAME TIME WHICH WAS IMPLANTED FIRST DISTALLY FOLLOWED BY THE 46/46/200 VALIANT CAPTIVIA WAS IMPLANTED SECOND PROXIMALLY. IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO THE HOSPITAL EMERGENTLY 19 DAYS POST OPERATIVELY DUE TO A RETROGRADE TYPE A DISSECTION. THE VALIANT STENT GRAFT WAS EXPLANTED AND REPLACED WITH A SYNTHETIC PROSTHESIS. THE DISSECTION ENTRY WAS CONFIRMED AT SMALLER CURVATURE OF AORTA AND THE PHYSICIAN INFERRED THAT THIS DISSECTION WAS NOT RELATED TO THE DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT THE DISSECTION WAS ACTUALLY A TYPE B DISSECTION. THE DISSECTION STARTED FROM THE DISTAL AORTIC ARCH TO DESCENDING THORACIC AORTA. THE OTHER MANUFACTURER'S DEVICE WAS IMPLANTED IN AN AREA OF THE DESCENDING THORACIC AORTA THAT MEASURED 33 MM IN DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317294 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04050532

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention