BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2000664 · Received February 16, 2011

    Report

    Report Number
    2953200-2011-00417
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ENDOLEAK). EVALUATION, RESULTS/CONCLUSION: (MODERATELY ANGULATED AND THROMBOSIS AORTIC NECK, AND HAD AN AREA OF 3-4MM X 2MM CALCIFICATION IN THE POSTERIOR AORTIC NECK).

    Description of Event or Problem · 1

    A TALENT STENT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.5 CM THORACIC AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS 23.5 MM IN DIAMETER AT THE RENAL ARTERIES AND 25 MM IN DIAMETER ABOVE THE AAA, MODERATELY ANGULATED, HAD THROMBUS, AND HAD AN AREA OF 3-4MM X 2MM CALCIFICATION IN THE POSTERIOR NECK. THE ILIAC ARTERIES WERE CALCIFIED. IT WAS REPORTED THAT AFTER THE INITIAL IMPLANTATION OF THE GRAFTS AND MODELING WITH A RELIANT BALLOON, A POST ANGIOGRAM SHOWED A SIGNIFICANT PROXIMAL TYPE I ENDOLEAK; HOWEVER, REPEAT BALLOONING DID NOT IMPROVE THE LEAK. THE PHYSICIAN EXTENDED PROXIMALLY BY 3-4MM WITH A CUFF (REF MFR 2953200-2011-00418), WHICH GREATLY IMPROVED THE LEAK, BUT STILL A PERSISTENT PROXIMAL TYPE I ENDOLEAK REMAINED. NO FURTHER INTERVENTION WAS PERFORMED, AND THE PT WILL BE MONITORED WITH A 30 DAY CT FOLLOW-UP. WILL MONITOR IN 30 DAYS. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA NA V00797508

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention