BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO

    MDR report key: 1910639 · Received November 22, 2010

    Report

    Report Number
    2953200-2010-02294
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: (ENDOLEAK), (HEAVILY CALCIFIED AND DISEASE AORTA). CONCLUSIONS: (HEAVILY CALCIFIED AND DISEASED AORTA).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE AORTA WAS HEAVILY CALCIFIED AND DISEASED THROUGHOUT. THE AORTIC NECK HAD A 30 DEGREE ANGULATION, IT WAS 26-29 MM IN DIAMETER FROM PROXIMAL TO DISTAL OVER 10-15 MM DISTANCE. IT WAS REPORTED THAT 32 MM DIAMETER WAS ATTEMPTED TO BE INSERTED; HOWEVER, IT WOULD NOT ADVANCE. IT WAS REMOVED FROM THE PT AND DISCARDED. THE DEVICE DID NOT KINK. ANOTHER SMALLER BIFURCATED STENT GRAFT WAS ABLE TO BE INSERTED AND DEPLOYED; HOWEVER , THERE WAS A PROXIMAL TYPE 1 ENDOLEAK PRESENT. TWO PALMAZ STENTS WERE IMPLANTED PROXIMALLY AND RESOLVED THE ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT A RECENT CT DEMONSTRATED A FABRIC TYPE III ENDOLEAK. THE PALMAZ STENT ERODED THROUGH THE FABRIC OF THE TALENT STENT GRAFT CREATING THE ENDOLEAK. THERE WAS SEVERE CALCIFICATION IN THE VESSELS. THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO ENDURANT AORTIC CUFFS AND THE TYPE III ENDOLEAK WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00547027

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention