BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 2230692 · Received August 17, 2011

    Report

    Report Number
    2953200-2011-01450
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (ENDOLEAK, CONVERSION TO OPEN REPAIR).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 8 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 2 YEARS AGO. VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS NOT REPORTED. IT WAS REPORTED THAT THE PATIENT PRESENTED APPROXIMATELY 1 MONTH AGO WITH ABDOMINAL PAIN. A CTA IDENTIFIED AN 8 CM ANEURYSM AND AN UNKNOWN TYPE OF ENDOLEAK, WHICH THE PHYSICIAN SUSPECTED TO BE A TYPE II ENDOLEAK. THE PHYSICIAN ELECTED TO PERFORM AN OPEN REPAIR OF THE ENDOLEAK. UPON OPENING THE PATIENT, EXISTING CLOT WAS REMOVED, AND FRESH BLOOD WAS SEEN IN AND AROUND THE AORTIC BIFURCATION SLIGHTLY ABOVE THE GATE; THE PHYSICIAN COMMENTED THAT THERE HAD BEEN A CONSTANT WEEPING OF BLOOD (A TYPE IV ENDOLEAK) THROUGH THE STENT GRAFT OVER THE 2 YEARS SINCE IMPLANTATION. THE BIFURCATED STENT GRAFT WAS EXPLANTED, AND A DACRON GRAFT WAS SEWN ONTO THE ANEURX LIMBS THAT WERE IN PLACE AND WELL INCORPORATED INTO THE VESSEL WALL, SUCCESSFULLY RESOLVING THE ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE. THE EXPLANTED STENT GRAFT WAS RETAINED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00107118N

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention