BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA - FF

    MDR report key: 7777085 · Received August 13, 2018

    Report

    Report Number
    2953200-2018-01162
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    July 20, 2018
    Report Date
    August 13, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE A TYPE IA ENDOLEAK WAS DETECTED. THE PROXIMAL LANDING LENGTH WAS APPROXIMATELY 50MM AND THERE WAS NEITHER CALCIFICATION NOR THROMBUS. THE STENT GRAFT WAS FULLY ENGAGED USING A NON-MEDTRONIC BALLOON, BUT THE ENDOLEAK WAS NOT RESOLVED COMPLETELY. TWO DAYS AFTER THE INDEX PROCEDURE, AN ADDITIONAL VALIANT STENT GRAFT WAS IMPLANTED. A NON-MEDTRONIC VASCULAR PLUG WAS ALSO PLACED IN THE LEFT SUBCLAVIAN ARTERY AND NON-MEDTRONIC COILS ADDITIONALLY PLACED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620215 VALIANT CAPTIVIA - FF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND VAMF3030C200TJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention