BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA

    MDR report key: 4233405 · Received November 6, 2014

    Report

    Report Number
    2953200-2014-02348
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 6.1 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT APPROXIMATELY 4 YEARS POST INDEX, THE PATIENT REPORTED TO THE ER COMPLAINING OF BACK PAIN. A CT SCAN WAS PERFORMED, REVEALING A TYPE I ENDOLEAK DUE TO MIGRATION OF THE BIFURCATE. AT PRESENT, THE STENT GRAFT FABRIC IS 15 MM BELOW THE LOWEST LEFT RENAL ARTERY. THE PHYSICIAN STATED THAT THE MIGRATION WAS DUE TO PROGRESSIVE NECK DILATATION. AN INTERVENTION WAS PERFORMED, WITH THE IMPLANT OF AN ENDURANT CUFF AND THE PLACEMENT OF APTUS SCREWS. THE ENDOLEAK WAS RESOLVED, AND THE PATIENT DID WELL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS STABLE. REVIEW OF CTA¿S 4 YEARS POST-IMPLANT CONFIRMED THAT THE TALENT BIFURCATE WAS APPROXIMATELY 2CM BELOW THE RENAL ARTERIES, AND THERE WAS A PROXIMAL TYPE I ENDOLEAK. THE STENT GRAFT PROXIMAL OD WAS 27 X 30MM, THE FLOW LUMEN DIAMETER JUST BELOW THE RENAL ARTERIES IS 25 X 29MM, AND THERE IS LESS THAN 1CM OF PROXIMAL SEAL LENGTH. THE MAXIMUM AAA DIAMETER IS 7CM. BOTH LIMBS ARE PATENT. ANGIO IMAGES DURING THE INTERVENTION SHOWED THAT AN ENDURANT CUFF WAS IMPLANTED JUST BELOW THE RENAL ARTERIES. APTUS SCREWS WERE ALSO PLACED JUST BELOW THE RENAL ARTERIES. THE ENDOLEAK APPEARED TO HAVE RESOLVED FOLLOWING THE INTERVENTION. EARLIER FOLLOW-UP IMAGES WERE NOT PROVIDED. THE EXACT CAUSE OF THE PROXIMAL TYPE I IS UNCERTAIN, BUT WAS LIKELY DUE TO THE REPORTED DISEASE PROGRESSION; NECK DILATATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712617 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00423425

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention