BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 4181817 · Received October 17, 2014

    Report

    Report Number
    2953200-2014-02114
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    May 12, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: ABDOMINAL AORTIC ANEURYSM CALCIFICATION AND THROMBUS VOLUME ARE NOT ASSOCIATED WITH OUTCOME FOLLOWING ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR. DIVYAJEET RAI, BRENDAN WISNIOWSKI, BARBARA BRADSHAW, RAMESH VELU <(>&<)> PATRIK TOSENOVSKY, FRANCIS QUIGLEY, PHILIP J. WALKER, JONATHAN GOLLEDGE. DOI 10.1007/S00330-014-3185-Y. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: ENDOLEAK TYPE I, GRAFT INFECTION, GRAFT KINKING, GRAFT THROMBOSIS/OCCLUSION, GRAFT MIGRATION, AND DEATH, TYPE II ENDOLEAK. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. OBJECTIVES AORTIC CALCIFICATION AND THROMBUS HAVE BEEN POSTULATED TO WORSEN OUTCOME FOLLOWING ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR). THE PURPOSE OF THIS STUDY WAS TO ASSESS THE ASSOCIATION OF ABDOMINAL AORTIC ANEURYSM (AAA) CALCIFICATION AND THROMBUS VOLUME WITH OUTCOME FOLLOWING EVAR USING A REPRODUCIBLE, QUANTIFIABLE COMPUTED TOMOGRAPHY (CT) ASSESSMENT PROTOCOL. METHODS PATIENTS WITH ELECTIVE EVAR PERFORMED BETWEEN JANUARY 2002 AND 2012 AT THE (B)(6) HOSPITAL WERE INCLUDED IF PREOPERATIVE CTAS WERE AVAILABLE FOR ANALYSIS. AAA CALCIFICATION AND THROMBUS VOLUME WERE MEASURED USING A SEMIAUTOMATED WORKSTATION PROTOCOL. OUTCOMES WERE ASSESSED IN TERMS OF CLINICAL FAILURE, ENDOLEAK (TYPE I, TYPE II) AND REINTERVENTION. UNIVARIATE AND MULTIVARIATE ANALYSES WERE PERFORMED. MEDIAN FOLLOW-UP WAS 1.7 YEARS AND THE INTERQUARTILE RANGE 1.0¿ 3.8 YEARS. RESULTS ONE HUNDRED THIRTY-FOUR PATIENTS UNDERGOING ELECTIVE EVAR WERE INCLUDED IN THE STUDY. RATES OF PRIMARY CLINICAL SUCCESS AND FREEDOM FROM REINTERVENTION WERE 82.8 % AND 88.9 % AT THE 24-MONTH FOLLOW-UP. AAA CALCIFICATION AND THROMBUS VOLUME WERE NOT ASSOCIATED WITH CLINICAL FAILURE, TYPE I ENDOLEAK, TYPE II ENDOLEAK OR REINTERVENTION. CONCLUSIONS AAA CALCIFICATION AND THROMBUS VOLUME WERE NOT ASSOCIATED WITH POORER OUTCOME AFTER EVAR IN THIS STUDY. KEY POINTS: THE ASSOCIATION OF CALCIFICATION AND THROMBUS VOLUMES WITH EVAR OUTCOME IS UNCLEAR; QUANTIFIABLE METHODS FOR ASSESSING CALCIFICATION AND THROMBUS WERE NOT USED PREVIOUSLY; THIS STUDY USED REPRODUCIBLE METHODS FOR ASSESSING AAA CALCIFICATION AND THROMBUS VOLUMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661942 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention