BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT WITH XCELERANT - HYDRO

    MDR report key: 2153206 · Received June 23, 2011

    Report

    Report Number
    2953200-2011-01194
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: ENDOLEAK, CAUSE OF JUNCTIONAL TYPE III ENDOLEAK IS UNKNOWN. CONCLUSION: CAUSE OF JUNCTIONAL TYPE III ENDOLEAK IS UNKNOWN.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AND COMMON ILIAC ARTERY ANEURYSMS APPROXIMATELY 2 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. DURING THE IMPLANT PROCEDURE, A 14X24X90 TALENT ILIAC FLARED LIMB WAS USED IN CONJUNCTION WITH A 28X28X40 ANEURX CUFF (MFR REPORT# 2953200-2011-01195) TO SEAL IN THE RIGHT COMMON ILIAC ARTERY IN ORDER TO PRESERVE THE INTERNAL ILIAC ARTERY. IT WAS REPORTED THAT THE PATIENT PRESENTED APPROXIMATELY 1 MONTH AGO WITH A JUNCTIONAL TYPE III ENDOLEAK, AS THE ANEURX CUFF BECAME SEPARATED FROM THE TALENT ILIAC LIMB IN THE RIGHT COMMON ILIAC ARTERY. THE PHYSICIAN ELECTED TO IMPLANT TWO LIMBS FROM ANOTHER MANUFACTURER AND A STENT FROM ANOTHER MANUFACTURER, WHICH SUCCESSFULLY RESOLVED THE TYPE III ENDOLEAK; HOWEVER, A DISTAL TYPE I ENDOLEAK WAS EVIDENT. THE PHYSICIAN THEN IMPLANTED A STENT FROM ANOTHER MANUFACTURER TO TREAT THE TYPE I ENDOLEAK AND ENDED UP COVERING THE RIGHT INTERNAL ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT STENT GRAFT WITH XCELERANT - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00252717

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention