BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA

    MDR report key: 4210430 · Received October 29, 2014

    Report

    Report Number
    2953200-2014-02227
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    June 22, 2011
    Report Date
    October 3, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    USE OF A BIFURCATED ENDOVASCULAR GRAFT FOR TREATMENT OF ENDOGRAFT MIGRATION WITH MAJOR ENDOLEAK. JEFFREY JIM, BRIAN G RUBIN AND LUIS A SANCHEZ DOI: 10.1258/VASC.2011.CR0285. ANEURYSM AND VESSEL MORPHOLOGY NOT REPORTED. ON UNKNOWN DATES, UNKNOWN TALENT AAA STENT GRAFTS WERE IMPLANTED. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE I ENDOLEAK, MIGRATION, DEATH, OCCLUSION, VESSEL COVERAGE BY STENT GRAFT (INTENTIONAL), TYPE II ENDOLEAK. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. THE PURPOSE OF THIS STUDY WAS TO DESCRIBE THE USE OF A BIFURCATED ENDOVASCULAR GRAFT TO TREAT ENDOGRAFT MIGRATION WITH MAJOR ENDOLEAKS. WE PRESENT FOUR PATIENTS WHO PRESENTED AT A MEAN OF 72.0 MONTHS AFTER THEIR INITIAL ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR. THREE PATIENTS HAD TYPE I ENDOLEAKS RESULTING FROM PROXIMAL ATTACHMENT FAILURE AND GRAFT MIGRATION. A FOURTH PATIENT HAD SEPARATION OF A PROXIMAL AORTIC CUFF FROM A MIGRATED MAIN BODY DEVICE RESULTING IN A TYPE III ENDOLEAK. ALL WERE TREATED WITH A BIFURCATED ZENITH (COOK MEDICAL INCORPORATED, BLOOMINGTON, IN, USA) ENDOVASCULAR GRAFT. THERE WAS 100% TECHNICAL SUCCESS WITH NO PERIOPERATIVE COMPLICATIONS. ON FOLLOW-UP, ONE PATIENT DIED OF UNRELATED CAUSES AT FIVE MONTHS. THE MEAN SURVIVAL FOR THE REMAINING THREE PATIENTS WAS 37 MONTHS. IN CONCLUSION, TREATMENT WITH A BIFURCATED ZENITH ENDOGRAFT HAS ADVANTAGES OVER THE USE OF AN AORTIC CUFF OR AORTOUNIILIAC RECONSTRUCTION. TO PERFORM THIS TECHNIQUE, THERE MUST BE A SUFFICIENT DISTANCE BETWEEN THE PROXIMAL LANDING ZONE AND THE FLOW DIVIDER OF THE MIGRATED ENDOGRAFT TO ALLOW FOR DEPLOYMENT OF THE ZENITH DEVICE. WHILE THERE REMAIN LIMITATIONS IN ITS APPLICABILITY, THE USE OF A BIFURCATED ENDOVASCULAR GRAFT IS A VIABLE ALTERNATIVE FOR ENDOVASCULAR SALVAGE IN TREATMENT OF ENDOGRAFT MIGRATION WITH MAJOR ENDOLEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692496 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention