BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2535439 · Received April 13, 2012

    Report

    Report Number
    2953200-2012-00782
    Event Type
    Death
    Date Received
    April 13, 2012
    Report Date
    March 20, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    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, INFECTION, OCCLUSION), 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. DELAYED COMPLICATIONS AFTER ENDOVASCULAR AAA REPAIR IN WOMEN BY MURRAY L. SHAMES, MD* ET AL. J ENDOVASC THER. 2003;10:10-15. THIS CLINICAL INVESTIGATION WAS TO ASSESS WHETHER WOMEN SUFFER MORE DELAYED COMPLICATIONS OR RE-QUIRE MORE INTERVENTIONS AFTER ENDOVASCULAR (AAA) REPAIR. OVER A 2-YEAR PERIOD, 245 PATIENTS (203 MEN, 42 WOMEN) UNDERWENT ENDOVASCULAR REPAIR WITH THE ANEURX STENT-GRAFT. BASELINE, OPERATIVE, AND FOLLOW-UP DATA WERE REVIEWED, AND OUTCOMES COMPARED BETWEEN MEN AND WOMEN FOR COMPLICATIONS BEYOND THE 30-DAY POST-OPERATIVE PERIOD. A DATABASE WAS USED TO RETRIEVE PATIENT INFORMATION (HISTORY OF SMOKING, ARTERY DISEASE, HYPERTENSION, COPD, DIABETES, CHRONIC RENAL INSUFFICIENCY, CEREBROVASCULAR DISEASE, PERIPHERAL VASCULAR DISEASE, AND ASA CLASSIFICATION), OPERATIVE DATA, PROCEDURAL RESULTS, COMPLICATIONS, AND SECONDARY INTERVENTIONS. THE 42 (17.1%) WOMEN TREATED WITH THE ANEURX GRAFT EXPERIENCED MORE TECHNICAL COMPLICATIONS (17% VERSUS 8.3%) AND ACUTE CONVERSIONS TO OPEN REPAIR (6/7, 86%). AT 30 DAYS, SYSTEMIC MORBIDITY WAS HIGHER IN WOMEN (26% VERSUS 5.3%) HOWEVER, MORTALITY (2.3% VERSUS 1.5%), LENGTH OF HOSPITAL STAY (2.6 VERSUS 2.9 DAYS), AND MAJOR ENDOLEAKS AT DISCHARGE (0% VERSUS 1.6%) WERE SIMILAR. OVER A MEAN FOLLOW-UP OF 11.3 MONTHS (RANGE 1-26), GRAFT LIMB OCCLUSION OCCURRED MORE IN FEMALE PATIENTS (12.2% VERSUS 2.5%), AND SECONDARY PROCEDURES WERE REQUIRED IN A HIGHER NUMBER OF WOMEN (29% VERSUS 9%). THREE PATIENTS IN EACH GROUP (25% OF WOMEN VERSUS 17% OF MEN) WHO HAD SECONDARY PROCEDURES REQUIRED ADDITIONAL INTERVENTIONS. A LIST OF RISK FACTORS IN PATIENTS RECEIVING ANEURX STENT GRAFT: AAA DIAMETER, SMOKER, CORONARY DIS-EASE, MYOCARDIAL INFARCTION, HYP RETENSION, COPD, DIABETES MELLITUS, RENAL INSUFFICIENCY, STROKE, ASA GRADE 3 OR 4. TECHNICAL COMPLICATIONS DURING GRAFT PLACEMENT WERE MORE FREQUENT IN WOMEN (17% VERSUS 8.3%). THE MAJORITY (89%) OF THESE COMPLICATIONS, WHICH INCLUDED DISSECTIONS, TRANSECTIONS, RUPTURES, AND PERSISTENT STENOSIS, OCCURRED DURING ACCESS/DELIVERY MANOEUVRES IN THE ILIAC OR FEMORAL ARTERIES. SECONDARY PROCEDURES AFTER AAA REPAIR: ARTERIAL RECONSTRUCTION, PROXIMAL EXTENSION OF DILATION OF THE PROXIMAL GRAFT, AMPUTATION, LYMPHOCELE DRAINAGE, PELVIC ABSCESS DRAINAGE, RENAL ARTERY REVASCULARIZATION, GRAFT REMOVAL, TYPE II ENDOLEAK EMBOLIZATION, AND COLON RESECTION. THERE WAS ONE OR MORE EACH OF THESE OCCURRENCES AMONG THE PATIENTS BEING STUDIED: DEATH, ENDOLEAKS, LIMB OCCLUSION, LIMB AMPUTATION, MYOCARDIAL INFARCTION, STROKE, GRAFT INFECTION, RENAL ARTERY OCCLUSION.

    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 SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1