BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA

    MDR report key: 3150724 · Received June 6, 2013

    Report

    Report Number
    2953200-2013-01084
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 16, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: STENT GRAFT MIGRATION, ENDOLEAK, ANEURYSM RUPTURE. DISEASE PROGRESSION. CONCLUSION: STENT GRAFT MIGRATION, ENDOLEAK, ANEURYSM RUPTURE. DISEASE PROGRESSION.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. THE PATIENT DID NOT RETURN FOR ANY FOLLOW-UP VISITS SINCE THE TIME OF IMPLANT. IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT PRESENTED TO THE HOSPITAL WITH A CONTAINED RUPTURED ANEURYSM. THE AORTIC NECK WAS FOUND TO HAVE DILATED TO 40 MM IN DIAMETER. THIS CAUSED THE BIFURCATED STENT GRAFT TO MIGRATE INTO THE ANEURYSM SAC WITH A PROXIMAL TYPE I ENDOLEAK PRESENT. THE DECISION WAS MADE TO EXPLANT THE TOP PORTION OF THE STENT GRAFT AND IT WAS REPLACED WITH A DACRON GRAFT WHICH WAS SEWN ONTO THE BODY OF THE STENT GRAFT AND TO THE AORTA. THE REMAINDER OF THE BIFURCATED STENT GRAFT AND THE ILIAC LIMBS WERE INTACT AND WERE LEFT IN PLACE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249870 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00274891

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention