BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM

    MDR report key: 2970482 · Received February 20, 2013

    Report

    Report Number
    2953200-2013-00302
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 26, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); LACK OF INFORMATION (CAUSE OF ENDOLEAK IS UNKNOWN). CONCLUSION: LACK OF INFORMATION (CAUSE OF ENDOLEAK IS UNKNOWN).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT ANGIOGRAPHY DONE THREE DAYS POST IMPLANT AND (B)(6) 2013 SHOWED QUICK FILLING INTO THE SAC FROM THE MIDDLE OF THE STENT GRAFT, WHICH THE PHYSICIAN BELIEVES WAS A TYPE IV JETTING ENDOLEAK. ANOTHER STENT GRAFT WAS IMPLANTED TO SUCCESSFULLY RESOLVE THE ENDOLEAK. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74563 VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01091196

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention