BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4219394 · Received November 3, 2014

    Report

    Report Number
    2953200-2014-02266
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; CLINICAL EFFICACY AND COST PER QUALITY-ADJUSTED LIFE YEARS OF PARARENAL ENDOVASCULAR AORTIC ANEURYSM REPAIR COMPARED WITH OPEN SURGICAL REPAIR. SULTAN S, HYNES N. J ENDOVASC THER. 2011 APR;18(2):181-96. AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN AORTIC ANEURYSM REPAIR. DURING THE RETROSPECTIVE STUDY THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: RENAL INSUFFICIENCY, MI, RESPIRATORY COMPLICATIONS, BOWEL ISCHEMIA, AND LOWER LIMB OCCLUSION, TYPE IA ENDOLEAK PURPOSE: TO GAUGE THE EFFICACY OF APPLYING COMMERCIALLY-AVAILABLE ENDOGRAFTS TO PARARENAL ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR COMPARED WITH OPEN SURGICAL REPAIR (OSR). METHODS: FROM 2001 TO 2009, 1868 AAA PATIENTS WERE REFERRED TO OUR SERVICE FOR EVALUATION; OF THESE, 118 PATIENTS HAD PARARENAL AAAS. SIXTY-SIX PATIENTS (51 MEN; MEAN AGE 70.8±7.6 YEARS) HAD OSR AND 52 (44 MEN; MEAN AGE 74.3±7.2 YEARS) UNDERWENT PARARENAL ENDOVASCULAR ANEURYSM REPAIR (EVAR). THE PARARENAL EVAR PATIENTS WERE OLDER (74.3 VERSUS 70.8 YEARS, P¿=¿0.014), WITH HIGHER MEAN COMORBIDITY SEVERITY SCORES (P¿=¿0.0001). MEAN ANEURYSM DIAMETER WAS LARGER IN THE OSR PATIENTS (6.6 VERSUS 5.9 CM, P¿=¿0.01). PRIMARY ENDPOINTS WERE ANEURYSM-RELATED SURVIVAL AND COST PER QUALITY-ADJUSTED LIFE YEARS (QALY). SECONDARY ENDPOINTS INCLUDED 3-YEAR FREEDOM FROM MAJOR ADVERSE CLINICAL EVENTS, ALL-CAUSE MORTALITY, AND SECONDARY INTERVENTION. RESULTS: THERE WAS NO PERIOPERATIVE MORTALITY IN THE PARARENAL EVAR GROUP VERSUS 3 (4.5%) DEATHS AMONG THE OSR PATIENTS (P¿=¿0.122). THE 15% 30-DAY MORBIDITY WITH PARARENAL EVAR WAS HALF THAT OF OSR (P¿=¿0.059). MEAN FOLLOW-UP WAS 28.8 ±21.6 MONTHS FOR PARARENAL EVAR AND 35.7±23.2 MONTHS FOR OSR. THERE WERE NO ANEURYSM RUPTURES IN EITHER GROUP AND NO CONVERSIONS TO OPEN REPAIR IN THE PARARENAL EVAR GROUP. THREE-YEAR ANEURYSM-RELATED SURVIVAL WAS SIGNIFICANTLY HIGHER WITH PARARENAL EVAR (100%) VERSUS OSR (92.4%, P¿=¿0.045), BUT THE FREEDOM FROM ANY-CAUSE DEATH WAS LOWER WITH PARARENAL EVAR (57.1%) THAN OSR (84.8%, P¿=¿0.195). THREE-YEAR FREEDOM FROM SECONDARY INTERVENTION (PARARENAL EVAR 83.4% VERSUS OSR 95.5%, P¿=¿0.301) AND ALL-CAUSE SURVIVAL (PARARENAL EVAR 57.1% VERSUS OSR 84.8%, P¿=¿0.195) WERE SIMILAR. OVER A 3-YEAR PERIOD, PARARENAL EVAR COSTS (INCLUDING FOLLOW-UP AND REINTERVENTION) AVERAGED ¿20,375 PER PATIENT TO GIVE A QALY VALUE OF 0.90, WHILE MEAN COSTS FOR OSR WERE ¿23,928 PER PATIENT (0.86 QALY). THE INCREMENTAL COST-EFFECTIVENESS RATIO FOR PARARENAL EVAR WAS ¿129,586 SAVED PER QALY GAINED. CONCLUSION: PARARENAL EVAR AFFORDED PATIENTS LONGER QUALITY-ADJUSTED TIME WITHOUT SYMPTOMS OR TOXICITY AND SUPERIOR FREEDOM FROM MAJOR ADVERSE EVENTS UP TO 3 YEARS. ALTHOUGH THE RELATIVELY LOW 3-YEAR SURVIVAL RATE REFLECTED THE GREATER COMORBIDITY OF THE EVAR PATIENTS, PARARENAL EVAR WAS COST-EFFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703931 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention