BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 2210580 · Received August 10, 2011

    Report

    Report Number
    2953200-2011-01421
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    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: GRAFT MIGRATION, ENDOLEAK, CONVERSION TO OPEN REPAIR. RESULTS/CONCLUSIONS: DISEASE PROGRESSION AND NO AORTIC NECK PRESENT.

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 18 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNK. IT WAS REPORTED THAT THE PT PRESENTED APPROXIMATELY 1 MONTH AGO WITH A PROXIMAL TYPE I ENDOLEAK, AND A CT DEMONSTRATED THAT THE STENT GRAFT WAS FOUND TO HAVE MIGRATED DISTALLY ALL THE WAY INTO THE ANEURYSM SAC. IT WAS NOTED THAT THE ANEURYSM HAS GROWN SIZE. THERE IS ILIAC FIXATION BILATERALLY ALL THE WAY TO THE HYPOGASTRIC ARTERIES. THE PT'S LAST FOLLOW-UP WAS 5 MONTHS AGO, AND NO MIGRATION WAS NOTED AT THE TIME. THE GRAFT MIGRATION WAS ATTRIBUTED TO DISEASE PROGRESSION, WHICH HAS RESULTED IN AN ABSENCE OF AN AORTIC NECK. THE PHYSICIAN ELECTED TO CONVERT THE PT TO OPEN REPAIR. NO ADDITIONAL 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 - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00414647

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention