BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT SYSTEM

    MDR report key: 2866653 · Received December 10, 2012

    Report

    Report Number
    2953200-2012-02372
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 29, 2012
    Report Date
    February 5, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (MIGRATION, ENDOLEAK), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION; AORTIC NECK DILATATION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION; AORTIC NECK DILATATION).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL AND ANEURYSM MORPHOLOGY AT THE TIME OF IMPLANT WAS NOT REPORTED. CURRENTLY THE PROXIMAL NECK MEASURES 29MM/32MM INNER TO INNER. THE GRAFT HAS MIGRATED APPROXIMATELY 4 CM DISTALLY FROM THE RENAL ARTERIES WITH A TYPE I ENDOLEAK PRESENT. OTHER THAN WHAT APPEARS TO BE CONTINUED PROXIMAL NECK DILATATION, ANATOMY WAS UNREMARKABLE INCLUDING ACCESS VESSELS, COMMON ILIAC ARTERIES AND PROXIMAL NECK WITH NO PLAQUE OR THROMBUS. THERE WAS SOME ANTERIOR MOVEMENT OF THE AORTA BETWEEN THE RENAL ARTERIES AND AORTIC BIFURCATION. THE PATIENT MONITORED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A SECONDARY INTERVENTION THREE MONTHS AGO. AN ENDURANT BIFURCATED STENT GRAFT 3616166, AND ILIAC LIMBS 1616124, 161682 AND A 161682 WERE IMPLANTED. THE TYPE I ENDOLEAK AND STENT GRAFT MIGRATION RESOLVED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR V00177920

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention