BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2535215 · Received April 13, 2012

    Report

    Report Number
    2953200-2012-00776
    Event Type
    Death
    Date Received
    April 13, 2012
    Report Date
    March 20, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH, OCCLUSION), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS: ANEURYSM-RELATED DEATH: PRIMARY ENDPOINT ANALYSIS FOR COMPARISON OF OPEN AND ENDOVASCULAR REPAIR. ARKO ET AL. J VASC SURG 2002;36:297-304. THE ANEURYSM-RELATED DEATH RATE COMBINES EARLY AND LATE DEATHS AND SHOULD BE USED AS THE PRIMARY OUTCOME MEASURE TO OBJECTIVELY COMPARE THE RESULTS OF OPEN AND ENDOVASCULAR REPAIR IN THE TREATMENT OF INFRARENAL ABDOMINAL AORTIC ANEURYSMS. IN OUR EXPERIENCE, ENDOVASCULAR ANEURYSM REPAIR REDUCED THE OVERALL ANEURYSM-RELATED DEATH RATE WHEN COMPARED TO OPEN REPAIR. SECONDARY PROCEDURES ARE REQUIRED AFTER BOTH OPEN AND ENDOVASCULAR REPAIR. HOWEVER, THE MAGNITUDE, MORBIDITY, AND MORTALITY OF SECONDARY PROCEDURES ARE REDUCED SIGNIFICANTLY WITH ENDOVASCULAR REPAIR. THE ANEURYSM-RELATED DEATH RATE WAS 0.6% (1/174) AFTER ENDOVASCULAR REPAIR (P <(><<)>(><(><<)><(><<)>)> .05). SECONDARY PROCEDURES WERE PERFORMED IN 27 PATIENTS FOLLOWING ENDOVASCULAR REPAIR. SECONDARY PROCEDURES FOLLOWING ENDOVASCULAR REPAIR CONSISTED OF PROXIMAL EXTENDER CUFFS (N = 11), DISTAL EXTENDER CUFFS (N = 11), LIMB THROMBOSIS (N = 3), AND SURGICAL CONVERSION (N =2). THE ANEURYSM RELATED DEATH WAS DUE TO MYOCARDIAL INFARCTION 3 WEEKS S/P PROCEDURE. SECONDARY PROCEDURES FOLLOWING ENDOVASCULAR REPAIR INCLUDED PLACEMENT OF PROXIMAL EXTENDER CUFFS (N =11) AND DISTAL EXTENDER CUFFS (N =11) TO SECURE STENT-GRAFT FIXATION, THROMBECTOMY FOR UNILATERAL LIMB THROMBOSIS (N =3), AND SURGICAL CONVERSION (N =2). THESE COMPLICATIONS PRESENTED WITHIN 30 POSTOPERATIVE DAYS IN FIVE PATIENTS (2.8%) AND BY LATE FOLLOW-UP IN 27 PATIENTS (15.2%). ANEURX BIFURCATED STENT GRAFTS UTILIZED FOR ALL ENDOVASCULAR REPAIRS IN THIS STUDY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1