BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT AAA

    MDR report key: 3910170 · Received July 2, 2014

    Report

    Report Number
    2953200-2014-01351
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: INTERVENTION WAS PERFORMED WITH IMPLANT OF AN ENDURANT CUFF TO THE PROXIMAL PORTION OF THE ORIGINALLY IMPLANTED TALENT BIFURCATED STENT GRAFT. IT WAS NOTED THAT THE TALENT BIFURCATED STENT GRAFT WAS NOT ORIGINALLY IMPLANTED DIRECTLY BELOW THE RENAL ARTERIES. THE CAUSE OF THE ENDOLEAK WAS DUE TO INSUFFICIENT SEALING ZONE. THE TYPE IA ENDOLEAK WAS RESOLVED AND PATIENT IS FINE.

    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. AT THE TIME OF DISCHARGE AND FOLLOW-UP NO ENDOLEAK WAS SEEN. FIVE DAYS POST IMPLANT A TYPE IA ENDOLEAK WAS CONFIRMED AND THE PATIENT WAS BEING MONITORED. FOUR MONTHS POST IMPLANT FOLLOW-UP CONFIRMED THAT THE TYPE IA ENDOLEAK WAS RESOLVED. APPROXIMATELY 11 MONTHS LATER POST-OPERATIVE FOLLOW-UP CONFIRMED THERE WAS TYPE IA ENDOLEAK FROM THE PROXIMAL END OF THE RIGHT SIDE OF THE STENT GRAFT AND THE DECISION WAS MADE TO MONITOR THE PATIENT. IT WAS REPORTED THAT APPROXIMATELY 26 MONTHS POST IMPLANT THERE WAS A TYPE IA ENDOLEAK NOTED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED. THE PHYSICIAN COMMENTED THAT THE ENDOLEAK WAS CAUSED BY THE SHORT LANDING ZONE. THERE HAS BEEN A 1CM GAP BETWEEN THE RENAL ARTERY AND THE PROXIMAL END OF THE TALENT BIFURCATED STENT GRAFT SINCE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386465 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention