BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2545562 · Received April 23, 2012

    Report

    Report Number
    2953200-2012-00843
    Event Type
    Death
    Date Received
    April 23, 2012
    Report Date
    March 29, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH, ENDOLEAK, SURGICAL CONVERSION, RUPTURE, RENAL FAILURE), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LIKELY ANATOMY RELATED). 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: DOES GENDER INFLUENCE OUTCOME OF AAA ENDOLUMINAL REPAIR?, G. PARLANI, EUR J VASC ENDOVASC SURG 26, 69-73 (2003). DURING A RETROSPECTIVE STUDY OF 402 PATIENTS TREATED FOR AAA COMPLICATIONS BETWEEN (B)(6) 1997 AND (B)(6) 2002, 231 TREATED WITH ANEURX AND 51 TREATED WITH TALENT, THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: PERIOPERATIVE DEATH, POSTOPERATIVE DEATH, MYOCARDIAL INFARCTION, CONGESTIVE HEART FAILURE, STROKE, ILIAC RUPTURE, RENAL INFARCTION, BOWEL OCCLUSION, RENAL ARTERY HEMORRHAGE, BLEEDING ULCER, MUCOSAL COLON ISCHEMIA, GRAFT OCCLUSION, LIMB AMPUTATION, SUBDURAL HEMATOMA, AAA RUPTURE, CONVERSION TO OPEN REPAIR, TYPE I ENDOLEAK, ANEURYSM ENLARGEMENT. RESULTS: THERE WERE NO PERIOPERATIVE DEATHS IN THE FEMALE GROUP AND 5 (1.3%) IN THE MALE GROUP (P.0.8). MAJOR PERIOPERATIVE MORBIDITY OCCURRED IN 17% VERSUS 6% (OR 3.7; 95% CI 1.2±10.6; P.0.026). THERE WERE 1 (4%) AND 5 (1%) CONVERSIONS TO OPEN REPAIR IN THE FEMALE AND MALE GROUPS, RESPECTIVELY (P.0.3). LATE FAILURE OF AAA EXCLUSION OCCURRED IN 5 (21%) AND 26 (7%) PATIENTS, RESPECTIVELY (P.0.03). OF THE FIVE VARIABLES EXAMINED FOR THEIR INFLUENCE ON FAILURE OF AAA EXCLUSION, FEMALE GENDER (HAZARD RATIO 4.42; 95% CI 1.4±13.4; P.0.009) AND AAA DIAMETER (HAZARD RATIO 1.05; 95% CI 1.009±1.09; P.0.017), WERE POSITIVE INDEPENDENT PREDICTORS OF LATE FAILURE OF AAA EXCLUSION ON MULTIVARIATE ANALYSIS. CONCLUSION: ENDOLUMINAL AAA REPAIR IN FEMALE PATIENTS APPEAR ASSOCIATED WITH A LESS FAVORABLE OUTCOME WHEN COMPARED TO THEIR MALE COUNTERPARTS. THESE DATA MAY BE TAKEN INTO CONSIDERATION WHEN ENDOLUMINAL AAA REPAIR IS SUGGESTED TO A FEMALE PATIENT.

    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 Required Intervention