BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA

    MDR report key: 3892853 · Received June 24, 2014

    Report

    Report Number
    2953200-2014-01270
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    March 19, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THE PATIENT HAD BEEN IN FOR YEARLY ROUTINE FOLLOW-UP APPOINTMENTS. FIVE YEARS POST INDEX PROCEDURE THE PATIENT WAS IN FOR THEIR YEARLY FOLLOW UP AND THE ULTRASOUND FOUND THAT THERE WAS SAC ENLARGEMENT FROM 5.3 CM TO 7.8 CM IN DIAMETER. THE FOLLOWING MONTH THE PATIENT HAD A CT ANGIOGRAM THAT SHOWED A CLEAR LEAK OF CONTRAST INTO THE ANEURYSM SAC. THE NEXT MONTH THE PATIENT HAD A CATHETER ANGIOGRAM THAT SHOWED A CLEAR LEAK OF CONTRAST INTO THE ANEURYSM SAC. CONTRAST WAS INJECTED INTO THE BODY OF THE GRAFT AND IT APPEARS THAT THERE IS A DEFECT IN THE FABRIC ABOVE THE FLOW DIVIDER. A CT ANGIOGRAM WAS DONE SHOWING AN ENDOLEAK. THE PATIENT WAS TREATED A COUPLE WEEKS LATER. THE PROCEDURE WENT WELL. THE PATIENT WILL BE MONITORED BY THE PHYSICIAN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. A REVIEW OF RETURNED FILMS AT IMPLANT REVEALED THAT THE MAIN DEVICE WAS BROUGHT UP THE LEFT SIDE. THE IPSI LIMB WAS PLACED INTO THE LEFT COMMON ILIAC AND THE CONTRA LIMB INTO THE RIGHT COMMON ILIAC. THE NECK AND AORTIC BODY WERE ESSENTIALLY STRAIGHT, AND THE DISTAL END OF THE LIMBS WERE EACH SLIGHTLY FLARED OUT LATERALLY. NO ENDOLEAK OR OTHER STENT GRAFT ISSUES WERE OBSERVED. CTA'S 5 YEARS POST-IMPLANT REVEALED THAT THE BIFURCATE WAS POSITIONED JUST BELOW THE RENAL ARTERIES. THE PROXIMAL STENT GRAFT OD IS 29MM, AND THERE IS APPROXIMATELY 1CM OF PROXIMAL SEAL LENGTH. CONTRAST IS SEEN NEAR THE TOP OF THE AAA SAC, NEAR THE RIGHT/CONTRA SIDE OF THE STENT GRAFT. THE ENDOLEAK TYPE CANNOT BE DETERMINED; THIS MAY BE EITHER A PROXIMAL TYPE I, A TYPE II FROM VISIBLE POSTERIOR LUMBARS, OR A TYPE III FABRIC ENDOLEAK. THE MAX DIAMETER AAA IS 8.4CM. ANGIOGRAM IMAGES SHOWED CONTRAST IN THE AAA SAC. THE TYPE OF ENDOLEAK COULD NOT BE DETERMINED; HOWEVER, CATHETER INTERROGATION OF THE ENDOLEAK SHOWS A POSSIBLE TYPE III FABRIC ENDOLEAK COMING FROM THE RIGHT SIDE OF THE AORTIC BODY, JUST ABOVE THE FLOW DIVIDER. THE CAUSE OF THE ENDOLEAK IS UNCERTAIN. NO STENT GRAFT ISSUES ARE OBSERVED. THE STENT GRAFT AORTIC BODY APPEARS ESSENTIALLY STRAIGHT WITH NO STENT OVERLAP SEEN IN THIS LOCATION, AND LITTLE CALCIFICATION IS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368450 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR V00175689

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention