BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT SYSTEM

    MDR report key: 2821641 · Received November 6, 2012

    Report

    Report Number
    2953200-2012-02129
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 11, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). (UNKNOWN CAUSE). CONCLUSION: (UNKNOWN CAUSE).

    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. ANEURYSM AND VESSEL MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A CONTAINED RUPTURED ANEURYSM TO THE PHYSICIAN'S OFFICE. THE PATIENT WAS SENT TO THE HOSPITAL FOR TREATMENT. THE CT REVEALED THAT THERE WAS A PROXIMAL TYPE I ENDOLEAK PRESENT. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT ENCF2828C49E AND THE ENDOLEAK WAS RESOLVED. NO 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 SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00225918

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention