BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2535453 · Received April 13, 2012

    Report

    Report Number
    2953200-2012-00786
    Event Type
    Death
    Date Received
    April 13, 2012
    Report Date
    March 20, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (DEATH, ENDOLEAK, RUPTURE, RENAL FAILURE, MI), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LIKELY ANATOMY RELATED). EVALUATION . CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LIKELY ANATOMY RELATED).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS: GENDER-RELATED DIFFERENCES IN INFRARENAL AORTIC ANEURYSM MORPHOLOGIC FEATURES: ISSUES RELEVANT TO ANCURE AND TALENT ENDOGRAFTS VELAZQUES ET AL. J VASC SURG 2001;33:S77-84. THE TOTAL NUMBER OF PATIENTS HAVING UNDERGONE EVAR WERE 88 (N=88). MAJOR ADVERSE EVENTS INCLUDED: UNPLANNED CONVERSION TO OPEN SURGICAL REPAIR (1), ILIAC ARTERY RUPTURE (2), UNABLE TO ACCESS/ABORTED CASE (1), ANCHORING SITE ENDOLEAKS (2). PERIOPERATIVE MORBIDITY AND DEATH WERE ASSOCIATED WITH PNEUMONIA (1), MYOCARDIAL INFARCTION (1), RENAL FAILURE (1), AND INPATIENT PERIOPERATIVE DEATH(S) (4). THE 2 ILIAC RUPTURES WERE RELATED TO OVERLY AGGRESSIVE BALLOONING AT THE DISTAL FIXATION POINT OF TALENT GRAFTS WITH UNCOVERED BARE SPRINGS AS THE DISTAL FIXATION. BOTH OF THESE PATIENTS WERE TREATED WITH AN IMMEDIATE ENDOVASCULAR PLACEMENT OF A LIMB EXTENSION. BOTH OF THESE PATIENTS DID WELL IN THE PERIOPERATIVE PERIOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1