BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 4102580 · Received September 19, 2014

    Report

    Report Number
    2953200-2014-01872
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 26, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 90 MM TAPERED THORACIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE DIAMETER OF THE PROXIMAL AORTIC NECK IS 29MM AND 40MM IN LENGTH. THE DIAMETER OF THE DISTAL AORTIC NECK IS 30MM AND 130MM LENGTH OF DISTAL NECK. THE PATIENT RECEIVED AN ADJUNCTIVE PROCEDURE PRIOR TO THE VALIANT THORACIC STENT GRAFT. REVASCULARIZATION OF THE LSA. DURING THE INDEX PROCEDURE, NO TECHNICAL OBSERVATIONS WERE NOTED AND DELIVERY AND DEPLOYMENT OF THE VALIANT STENT GRAFT WAS SUCCESSFUL. DURING FOLLOW UP A CT WITH CONTRAST NOTED EVIDENCE OF A TYPE II ENDOLEAK. NO SECONDARY INTERVENTION WAS PERFORMED. (IMPORTANT COLLATERAL RE-ENTRY IMMEDIATELY BELOW OF THE COARCTATION TREATED). IN ADDITION, SMALL IMAGES OF THROMBI ADHERENT TO THE STENT GRAFT WERE NOTED. NO SECONDARY INTERVENTION WAS PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582781 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01711591

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR