BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT

    MDR report key: 4123417 · Received September 26, 2014

    Report

    Report Number
    2953200-2014-01949
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 15, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A TALENT AAA STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS SUFFERING FROM BACK PAIN AND SOUGHT RELIEF. ON A FOLLOW UP CT SCAN, THE BIFURCATE HAD MIGRATED INTO THE ANEURYSM SAC CAUSING A PROXIMAL TYPE I ENDOLEAK. THE BIFURCATED DEVICE WAS NOT SALVAGEABLE VIA ENDOVASCULAR MEANS AS THE PROXIMAL SUPRARENAL CROWNS HAD INCORPORATED INTO THE THROMBUS PRESENT IN THE DISEASED AORTA. THE GRAFT HAD LAID OVER IN THE AORTA APPROXIMATELY 85 DEGREES FROM ITS ORIGINAL IMPLANTED POSITION THUS CONTRIBUTING TO THE PHYSICIANS DECISION TO EXPLANT THE GRAFT. A DACRON GRAFT WAS SEWN INTO THE PATIENT TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600313 TALENT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00385964

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention