BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1051123 · Received May 22, 2008

    Report

    Report Number
    2953200-2008-00346
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    March 28, 2008
    Report Date
    April 29, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (REQUIRED SECONDARY INTERVENTION).

    Description of Event or Problem · 1

    A 26 MM DIAMETER X 16 MM DIAMETER X 170 MM LENGTH TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 39 MONTHS AGO. THE DIAMETER OF THE AORTIC NECK AT THE TIME OF IMPLANT WAS 22 MM. ANEURYSM MORPHOLOGY WAS NOT REPORTED. THE PROCEDURE WAS UNEVENTFUL WITH SUCCESSFUL ANEURYSM REPAIR. IT WAS REPORTED THAT DURING AN ANNUAL CT SCAN APPROX 3 YEARS POST IMPLANT, THERE WAS INCREASE IN DIAMETER OF THE PROXIMAL AORTA FROM 22 MM TO 26 MM. THERE WAS 70 MM CAUDAL MIGRATION OF THE BIFURCATED STENT GRAFT AND A TYPE 1 ENDOLEAK WAS PRESENT. THE PT WAS BROUGHT BACK THE NEXT MONTH TO ATTEMPT REPAIR WITH A TALENT BIFURCATED STENT GRAFT ON XCELERANT DELIVERY SYSTEM. DEPLOYMENT OF THE STENT GRAFT WAS UNSUCCESSFUL (SEE MFR# 2953200-2008-00347). TWO ADD'L ATTEMPTS WERE MADE WITH AORTO-UNI-ILIAC STENT GRAFTS ON XCELERANT DELIVERY SYSTEMS; HOWEVER, DEPLOYMENT OF THE STENT GRAFTS WAS UNSUCCESSFUL (SEE MFR# 2953200-2008-00348 AND MFR# 2953200-2008-00349). THE PROCEDURE WAS ENDED WITH THE PT UNTREATED AND THE DECISION WAS TO PERFORM THE ENDOVASCULAR REPAIR WITH ANOTHER MFR'S DEVICE AT A LATER DATE. NO ADD'L CLINICAL SEQUELAE WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention