BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT AAA

    MDR report key: 3484560 · Received November 22, 2013

    Report

    Report Number
    2953200-2013-02312
    Event Type
    Death
    Date Received
    November 22, 2013
    Date of Event
    August 30, 2013
    Report Date
    January 30, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: FILM EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: DEATH, MIGRATION, ENDOLEAK, ANEURYSM RUPTURE. PATIENT WAS LOST TO FOLLOW UP. CAUSE OF EVENTS ARE UNKNOWN. CONCLUSIONS: PATIENT WAS LOST TO FOLLOW UP. CAUSE OF EVENTS ARE UNKNOWN. DEATH, MIGRATION, ENDOLEAK, ANEURYSM RUPTURE.

    Additional Manufacturer Narrative · 1

    METHOD: FILM EVALUATION. RESULTS, CONCLUSIONS: NECK DILATATION.

    Description of Event or Problem · 1

    A FILM EVALUATION NOTED THAT POST-IMPLANT IMAGES FROM 4-1/2 YEARS SHOWED THAT THE TALENT BIFURCATE WAS POSITIONED APPROXIMATELY 1.5CM BELOW THE LOWEST RENAL. THE IPSILATERAL LIMB WAS PLACED INTO THE RIGHT COMMON ILIAC, AND THE CONTRALATERAL LIMB INTO THE LEFT COMMON ILIAC. THERE WAS A PROXIMAL TYPE I ENDOLEAK. THE MAXIMUM AAA DIAMETER WAS APPROXIMATELY 10.5CM. BOTH LIMBS WERE PATENT. THE AORTIC NECK/BIFURCATE BODY WAS ANGULATED APPROXIMATELY 65DEG A-P AND 60DEG L-R. THE PROXIMAL NECK DIAMETER AT THE RENAL ARTERIES WAS 22MM, AND THE PROXIMAL STENT GRAFT OD WAS 30 X 31MM. THE ANATOMY AT IMPLANT IS UNKNOWN, AND EARLIER POST-IMPLANT IMAGES WERE NOT RETURNED, THEREFORE ANY POSSIBLE IN-VIVO CONFIGURATION CHANGES COULD NOT BE ASSESSED. THE CAUSE OF THE STENT GRAFT MIGRATION, LEADING TO THE TYPE IA ENDOLEAK, COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    FILM EVALUATION: CTA'S FROM 1-MONTH POST-IMPLANT SHOWED THAT THE BIFURCATE WAS POSITIONED SEVERAL MM'S BELOW THE RENAL ARTERIES. THE NECK ID AT THE LEFT RENAL WAS 21 X 26. THE PROXIMAL S-G OD IS 21MM. THE PROXIMAL NECK WAS ANGULATED 50DEG A-P AND 30DEG L-R. THE IPSILATERAL LIMB WAS PLACED INTO THE RIGHT COMMON ILIAC, AND THE CONTRA INTO THE LEFT COMMON ILIAC. THE MAX AAA DIAMETER WAS 7.1CM. NO ENDOLEAK WAS SEEN, THE LIMBS WERE PATENT. CTA FROM 7-MONTHS POST IMPLANT SHOWED THAT THE STENT GRAFT HAS MIGRATED DISTALLY (APPROX 5-10MM) AS COMPARED TO THE PREVIOUS STUDY. THE NECK DIAMETER AT THE LEFT RENAL IS 21X27MM. THE MAX AAA DIA IS 7.1CM. NO ENDOLEAK IS SEEN. THE CAUSE OF THE MIGRATION MAY BE DUE TO NECK DILATATION.

    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 APPROXIMATELY FOUR YEARS AGO. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ER EMERGENTLY WITH A RUPTURED ANEURYSM. THE DEVICE HAD MIGRATED RESULTING IN A PROXIMAL TYPE I ENDOLEAK. THE PATIENT HAD NOT BEEN IN FOR REGULAR FOLLOW UP APPOINTMENTS. THE PHYSICIAN DID NOT GET A CHANCE TO ATTEMPT TO TREAT THE PATIENT. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608893 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR V00188476

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Death