BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2545558 · Received April 23, 2012

    Report

    Report Number
    2953200-2012-00842
    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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (DEATH, ENDOLEAK, SURGICAL CONVERSION). 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: THE EFFECT OF GENDER ON EARLY AND INTERMEDIATE RESULTS OF ENDOVASCULAR ANEURYSM REPAIR, PAUL J. NORDNESS, ANN VASC SURG 2003; 17: 615-621. DURING A RETROSPECTIVE STUDY OF 118 PATIENTS TREATED WITH ANEURX BETWEEN (B)(6) 1997 AND (B)(6) 2001 FOR AAA COMPLICATIONS, THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DEATH, SURGICAL CONVERSION, ANEURYSM RUPTURE, TYPE I ENDOLEAK, BYPASS, THROMBOLYSIS, EMBOLECTOMY, DISSECTION, RESPIRATORY FAILURE, CVA, RENAL FAILURE, LIMB OCCLUSION, FAILURE TO DEPLOY, ISCHEMIC COLITIS, WOUND INFECTION, TYPE II ENDOLEAK. RESULTS OF ENDOVASCULAR ANEURYSM REPAIR (EVAR) MAY BE GENDER DEPENDENT. BETWEEN (B)(6) 1997 AND (B)(6) 2001, 118 ANEURX_ AORTIC GRAFTS WERE PLACED FOR ANEURYSMAL DISEASE. DURING THIS PERIOD, 17 FEMALES AND 101 MALES WERE TREATED WITH THIS DEVICE. A PROSPECTIVE DATABASE WAS MAINTAINED AND SUPPLEMENTED WITH RETROSPECTIVELY GATHERED INFORMATION TO EVALUATE EARLY AND MID-TERM END POINTS. A TOTAL OF 113 DEVICES WERE DEPLOYED IN 118 ATTEMPTS. LENGTH OF PROCEDURE WAS GREATER FOR FEMALES (3.3 ± 1.75 VS. 2.3 ± 0.8 HR, P = 0.05) AND THEY WERE MORE LIKELY TO HAVE SIGNIFICANT ARTERIAL DISSECTIONS (12% VS. 1%, P = 0.05). THE MORTALITY RATES AT 1 MONTH WERE 12% FOR FEMALES AND 0% FOR MALES (P = 0.02); THE COMPLICATION RATES AT 1 MONTH WERE 41% FOR FEMALES AND 15% FOR MALES (P = 0.02). ALTHOUGH TECHNICAL SUCCESS WAS NOT SIGNIFICANTLY DIFFERENT BETWEEN THE SEXES, ASSISTED PRIMARY TECHNICAL SUCCESS (REQUIRING ENDOVASCULAR ASSISTANCE) AND ASSISTED SECONDARY TECHNICAL SUCCESS (REQUIRING OPEN SURGICAL ASSISTANCE) WERE SIGNIFICANTLY DIFFERENT (71% VS. 96%, P = 0.003; AND 76% VS. 98%, P = 0.004, RESPECTIVELY). CLINICAL SUCCESS AT 1 MONTH WAS 59% FOR FEMALES AND 84% FOR MALES (P = 0.02). THIS DIFFERENCE WAS ALSO SIGNIFICANT WHEN ASSESSING 1-MONTH ASSISTED PRIMARY CLINICAL SUCCESS (59% VS. 90%, P = 0.003) AND ASSISTED SECONDARY CLINICAL SUCCESS AS WELL (71% VS. 96%, P = 0.003). CLINICAL SUCCESS AND ASSISTED PRIMARY CLINICAL SUCCESS WERE NOT DIFFERENT AT 6- OR 12- MONTH INTERVALS, HOWEVER, ASSISTED SECONDARY CLINICAL SUCCESSES DIFFERED AT BOTH TIME INTERVALS (56% VS. 83%, P = 0.02; AND 56% VS. 81%, P = 0.05, RESPECTIVELY). AS-YET UNDETERMINED FACTORS APPEAR TO PREDISPOSE FEMALES TO COMPLICATIONS AND TECHNICAL DIFFICULTIES IN THE SHORT TERM. ENDOVASCULAR AND OPEN PROCEDURES REQUIRED TO ACHIEVE ONGOING CLINICAL SUCCESS IN THE FOLLOWING MONTHS APPEAR TO FAVOR MALES TO A GREATER DEGREE THAN FEMALES.

    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