BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT

    MDR report key: 4200672 · Received October 24, 2014

    Report

    Report Number
    2953200-2014-02184
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 14 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. AT IMPLANT, THE PROXIMAL AORTIC NECK DIAMETER MEASURED 33MM AND 20MM IN LENGTH. THE AORTIC NECK ANGULATION WAS 60 DEGREES. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH ABDOMINAL PAIN. A CT SCAN WAS DONE AND A PROXIMAL ENDOLEAK WAS OBSERVED IN ADDITION TO A DISTAL TYPE I ENDOLEAK COMING FROM THE LIMB AND THE BIFURCATE. AN ENDURANT CUFF AND THREE ILIAC LIMBS WERE IMPLANTED RESOLVING THE PROXIMAL AND DISTAL ENDOLEAKS. THE PATIENT WAS LOST TO FOLLOW UP AND A CT HAD NOT BEEN DONE SINCE THE IMPLANT SIX YEARS AGO. THE PHYSICIAN STATED THAT THE CAUSE OF THE ENDOLEAKS WERE DUE TO ANEURYSMAL DILATATION OF THE LEFT AND RIGHT COMMON ILIACS. THE ILIACS DISTAL TO THE ORIGINAL ILIAC ENDOGRAFT LIMBS DILATED TO BREAK SEAL. THIS IS ALSO TRUE AS IT RELATES TO THE INFRARENAL NECK. ANEURYSMAL DILATATION WAS THE CAUSE OF THE ENDOLEAK. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679669 TALENT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00110660

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention