BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA

    MDR report key: 3071838 · Received April 22, 2013

    Report

    Report Number
    2953200-2013-00752
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    February 3, 2012
    Report Date
    June 27, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). METHODS: (FILMS); RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). CONCLUSION: (INSUFFICIENT INFORMATION, CAUSE OF EVENTS IS UNKNOWN); KNOWN INHERENT RISK OF PROCEDURE (ENDOLEAK).

    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. THE ANEURYSM DIAMETER WAS 5.4 CM. ADDITIONAL ANEURYSM AND VESSEL MORPHOLOGY INFORMATION WAS NOT REPORTED. AT THE INDEX PROCEDURE THE PATIENT RECEIVED A TALENT (B)(4) BIFURCATED STENT GRAFT AND AN ANEURX (B)(4) LIMB. APPROXIMATELY THREE YEARS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH A PROXIMAL TYPE I ENDOLEAK. ENDURANT (B)(4) CUFFS WERE IMPLANTED, AND THE ENDOLEAK RESOLVED. APPROXIMATELY FOUR YEARS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH A TYPE III FABRIC ENDOLEAK. AN ENDURANT (B)(4) LIMB WAS IMPLANTED, AND THE ENDOLEAK RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF A SINGLE STILL ANGIO IMAGE SHOWED CONTRAST OUTSIDE OF THE STENTLESS AREA OF THE IPSILATERAL LIMB; POSSIBLY DUE TO A TYPE III FABRIC ENDOLEAK. AN IMAGE AFTER RELINING WITH A LIMB SHOWED RESOLUTION OF THE ENDOLEAK. THE CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED FROM THIS IMAGE.

    Description of Event or Problem · 1

    A REVIEW OF CTA'S 4 YEARS POST-IMPLANT SHOW THAT THE ENDURANT CUFF(S) WERE POSITIONED JUST BELOW THE RENAL ARTERIES. THE TALENT BIFURCATE WAS 2-3CM BELOW THE RENALS; THE ORIGINAL PLACEMENT OF THE TALENT IS UNKNOWN. THE AAA WAS 8CM MAX DIAMETER. THE IPSILATERAL LIMB WAS PLACED WITHIN THE LEFT ILIAC. THE AORTIC BODY WAS ANGULATED 90DEG TO THE LIMBS (A-P). BELOW THE ANGULATION, A POSSIBLE TYPE III FABRIC ENDOLEAK IS SEEN NEAR THE STENTLESS AREA OF THE IPSILATERAL LIMB IN THE DISTAL AAA SAC. THERE IS A LARGE AREA OF CALCIFICATION NEAR THE ENDOLEAK IN THE DISTAL AAA. THE CAUSE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT CALCIFICATION MAY HAVE ABRADED THE FABRIC AND CAUSED THE TYPE III ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171846 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR V00183523

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Required Intervention