BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 6509943 · Received April 20, 2017

    Report

    Report Number
    2953200-2017-00649
    Event Type
    Injury
    Date Received
    April 20, 2017
    Date of Event
    February 1, 2017
    Report Date
    March 29, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; COMPARISON OF RENAL COMPLICATIONS BETWEEN ENDOGRAFTS WITH SUPRARENAL AND INFRARENAL FIXATION. AUTHORS: S.L. ZETTERVALL, P.A. SODEN, S.E. DEERY, K. ULTEE, K.E. SHEAN, F. SHUJA, R.L. AMDUR, M.L. SCHERMERHORN. EUR J VASC ENDOVASC SURG (2017) -, 1-7 HTTP://DX.DOI.ORG/10.1016/J.EJVS.2017.02.001. AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE FOLLOWING INFORMATION IS IN THIS JOURNAL ARTICLE: INFECTION, MYOCARDIAL INFARCTION, PNEUMONIA, ISCHEMIA, PULMONARY EMBOLISM, RENAL FAILURE. OBJECTIVES: SURGEONS HAVE MULTIPLE GRAFTS OPTIONS AVAILABLE FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSM (EVAR), AND SOME HYPOTHESIZE THAT SUPRARENAL FIXATION ENDOGRAFTS MAY RESULT IN HIGHER RATES OF RENAL COMPLICATIONS THAN INFRARENAL ENDOGRAFTS. THIS STUDY AIMED TO COMPARE THE OUTCOMES OF CONTEMPORARY SUPRARENAL AND INFRARENAL ENDOGRAFTS. METHODS: THE TARGETED VASCULAR MODULE OF THE NATIONAL SURGICAL QUALITY IMPROVEMENT PROJECT WAS UTILISED TO IDENTIFY PATIENTS UNDERGOING EVAR FOR INFRARENAL ANEURYSM FROM 2011 TO 2013. PRE-OPERATIVE AND OPERATIVE VARIABLES AND 30 DAY OUTCOMES WERE COMPARED AMONG SUPRARENAL (ZENITH AND ENDURANT) AND INFRARENAL FIXATION DEVICES (EXCLUDER). RENAL COMPLICATIONS INCLUDED CREATININE INCREASE > 2 MG/DL OR NEW DIALYSIS, AS DEFINED BY NSQIP. MULTIVARIATE REGRESSION WAS COMPLETED TO ACCOUNT FOR PATIENT DEMOGRAPHICS, COMORBIDITIES, AND OPERATIVE CHARACTERISTICS. RESULTS: A TOTAL OF 3587 PATIENTS WERE EVALUATED INCLUDING 2273 (63%) WITH SUPRARENAL GRAFTS AND 1314 (37%) WITH INFRARENAL GRAFTS. PATIENTS WITH SUPRARENAL GRAFTS WERE LESS COMMONLY WHITE (84% VS. 88%, P <(><<)> .01) AND MORE COMMONLY MALE (83% VS. 80%, P = .03). THERE WERE NO DIFFERENCES IN AGE OR COMORBIDITIES. RENAL COMPLICATIONS (1.1% VS. 0.1%, P <(><<)> .01) AND LENGTH OF STAY MORE THAN 2 DAYS (34% VS. 25%, P <(> <<)> .01) OCCURRED MORE COMMONLY AFTER SUPRARENAL FIXATION. AFTER ADJUSTMENT, SUPRARENAL GRAFTS HAD SIGNIFICANTLY HIGHER RATES OF RENAL COMPLICATIONS (OR, 12.0; 95% CI, 1.6-91) AND LENGTH OF STAY MORE THAN 2 DAYS (OR, 1.4; 95% CI, 1.2-1.7). CONCLUSION: OVERALL RATES OF RENAL COMPLICATIONS FOLLOWING EVAR ARE LOW. PATIENTS SELECTED FOR SUPRARENAL STENT GRAFTS ARE AT INCREASED RISK OF RENAL COMPLICATIONS AND PROLONGED LENGTH OF STAY, WHICH MAY BE DUE TO SELECTION BIAS, DEPLOYMENT TECHNIQUES, OR THE PRESENCE OF A BARE STENT OVERLYING THE RENAL ARTERIES. FURTHER STUDIES ARE NECESSARY TO EVALUATE THE MECHANISM AND DURATION OF RENAL DYSFUNCTION AND IMPORTANT LONG-TERM OUTCOMES OF INTEREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291408 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R