BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA - FF

    MDR report key: 6174896 · Received December 15, 2016

    Report

    Report Number
    2953200-2016-02122
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    December 9, 2016
    Report Date
    December 9, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    UDI-DI
    00643169347366
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST INDEX PROCEDURE A CT REVEALED THAT THE VALIANT STENT GRAFT HAD A DISTAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL VALAINT STENT GRAFT AND EXTENDED COVERAGE TO THE LEVEL OF THE CELIAC TRUNK AND THE ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO UNDERSIZING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826772 VALIANT CAPTIVIA - FF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND VAMF3434C200TU 00643169347366

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention