BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT

    MDR report key: 2440232 · Received February 6, 2012

    Report

    Report Number
    2953200-2012-00243
    Event Type
    Injury
    Date Received
    February 6, 2012
    Report Date
    January 9, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT INFORMATION DOES NOT MATCH INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC. RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, CONVERSION TO OPEN REPAIR). UNKNOWN CAUSE OF EVENT. CONCLUSION: UNKNOWN CAUSE OF EVENT.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE, WHICH IS SUMMARIZED AS FOLLOWS: LONG-TERM FOLLOW-UP OF TYPE II ENDOLEAK EMBOLIZATION REVEALS THE NEED FOR CLOSE SURVEILLANCE, TIMUR P. SARAC, JOURNAL VASCULAR SURGERY 2012;55:33-40. A TALENT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY NOT REPORTED. ON AN UNKNOWN DATE, AN UNKNOWN TALENT AAA STENT GRAFT WAS IMPLANTED. DURING A RETROSPECTIVE STUDY OF 809 PATIENTS WHO UNDERWENT EVAR BETWEEN (B)(6) 1999 AND (B)(6) 2009, 95 WERE FOUND TO HAVE TYPE II ENDOLEAKS (3 OF WHICH WERE TALENT). OF THESE 95, EIGHT PATIENTS (8.4%) UNDERWENT GRAFT EXPLANT AND OPEN REPAIR; 19 (20%) REQUIRED TWO OR MORE EMBOLIZATION PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention