BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1940621 · Received December 22, 2010

    Report

    Report Number
    2953200-2010-02628
    Event Type
    Injury
    Date Received
    December 22, 2010
    Report Date
    November 30, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (ENDOLEAK). (TYPE 2 ENDOLEAK).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF A 6 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 24 MONTHS AGO. VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS REPORTED AS THE AORTIC NECK CHANGES FROM 21 MM IN DIAMETER AT THE RENAL ARTERIES AND 30 MM DISTALLY THE DIAMETER IS 29 MM IN DIAMETER. CURRENTLY, THE AORTIC NECK IS SHORT MEASURING 1-1.5 CM AND IT WAS FUNNEL SHAPED. IT WAS REPORTED THAT A RECENT CT DEMONSTRATED THAT THE STENT GRAFT HAS MIGRATED AND IS 1 CM BELOW THE RENAL ARTERIES WITH A TYPE 1 ENDOLEAK PRESENT. THEY WILL BE TREATED IN THE NEXT MONTH. NO ADDITIONAL CLINICAL SEQUELAE REPORTED, AND THE PT IS FINE. THE PT WAS TREATED WITH A 28 MM ANEURX CUFF FOLLOWED BY A 28 MM TALENT CUFF AND A PALMAZ STENT. THERE WAS STILL A SMALL ENDOLEAK; HOWEVER, IT WAS DETERMINED THE ENDOLEAK WAS A TYPE 2. NO FURTHER INTERVENTION WAS PERFORMED AT THIS TIME. APPROXIMATELY 1 MONTH AGO, IT WAS NOTED THERE WAS INCREASE IN THE ANEURYSM SIZE DUE TO THE TYPE 2 ENDOLEAK AND THE PHYSICIAN ELECTED TO EXPLANT THE STENT GRAFTS (SEE MFR # 2953200-2010-01653 AND MFR # 2953200-2010-02627). THE EXPLANTED STENT GRAFT WAS DISCARDED 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 GALWAY NA V00528755

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention