BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1841627 · Received September 16, 2010

    Report

    Report Number
    2953200-2010-01757
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ENDOLEAK), (CONICALLY SHAPED AORTIC NECK), (BIFURCATED GRAFT MAY HAVE BEEN PLACED LOW AT THE TIME OF IMPLANT). CONCLUSION: (CONICALLY SHAPED AORTIC NECK), (BIFURCATED GRAFT MAY HAVE BEEN PLACED LOW AT THE TIME OF IMPLANT).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 5.5 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED, OTHER THAN THAT THE AORTIC NECK WAS CONICALLY SHAPED. IT WAS REPORTED THAT THERE WAS A JUNCTIONAL TYPE III ENDOLEAK BETWEEN THE BIFURCATED STENT GRAFT (MFR REPORT # 2953200-2010-01757) AND THE PROXIMAL AORTIC CUFF (MFR REPORT # 2953200-2010-01758). THE BIFURCATED STENT GRAFT MAY HAVE BEEN PLACED LOW AT THE TIME OF IMPLANT. THE PHYSICIAN ELECTED TO INTERVENE BY PLACING TWO AORTIC CUFFS FROM ANOTHER MANUFACTURER, WHICH SUCCESSFULLY RESOLVED THE ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00217261

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention