BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1933733 · Received December 16, 2010

    Report

    Report Number
    2953200-2010-02566
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: (ENDOLEAK), (SEVERELY ANGULATED AND REVERSE FUNNEL SHAPED AORTIC NECK), (STENT GRAFT WAS IMPLANTED IN A PT WITH A SEVERELY ANGULATED AND REVERSE FUNNEL SHAPED AORTIC NECK). CONCLUSION: (SEVERELY ANGULATED AND REVERSE FUNNEL SHAPED AORTIC NECK), (STENT GRAFT WAS IMPLANTED IN A PT WITH A SEVERELY ANGULATED AND REVERSE FUNNEL SHAPED AORTIC NECK).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM ABDOMINAL AORTIC ANEURYSM APPROX 4 MONTHS AGO. THE AORTIC NECK WAS SHORT, REVERSE-CONICAL SHAPED AND RANGED FROM 20-28-32 MM IN DIAMETER OVER A LENGTH OF 15 MM, WITH SEVERE ANGULATION OF 70-80 DEGREES. IT WAS REPORTED THAT AT A ROUTINE F/U ON (B)(6) 2010, A SLIGHT PROXIMAL TYPE 1 ENDOLEAK WAS SEEN, LIKELY DUE TO THE SEVERE NECK ANATOMY. A 32 TALENT CUFF AND PALMAS STENT WERE PLACED TO SUCCESSFULLY RESOLVE THE ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00490955

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention