BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3675812 · Received March 12, 2014

    Report

    Report Number
    2953200-2014-00461
    Event Type
    Injury
    Date Received
    March 12, 2014
    Date of Event
    December 8, 2011
    Report Date
    February 17, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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; CANDIDATES AND MAJOR DETERMINANTS FOR ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS IN KOREAN PATIENTS. JOO MYUNG LEE, CHEONG LIM, TAE-JIN YOUN, EUN JU CHUN, SANG-IL CHOI, YOUNG-SEOK CHO, GOO-YEONG CHO, IN-HO CHAE, KAY-HYUN PARK, DONG-JU CHOI. DOI 10.1007/S00380-011-0221-6. DURING THE RETROSPECTIVE STUDY, THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE IA, TYPE IB, TYPE II, TYPE III ENDOLEAK. MAJOR COMPLICATIONS INCLUDED ACUTE RENAL FAILURE REQUIRING RENAL REPLACEMENT THERAPY, WOUND PROBLEMS THAT REQUIRED SURGICAL CORRECTION UNDER GENERAL ANAESTHESIA, DISTAL MALPERFUSION. ABSTRACT: THE PURPOSE OF THIS STUDY WAS TO DETERMINE WHAT PROPORTION OF PATIENTS WITH AN ABDOMINAL AORTIC ANEURYSM (AAA) WOULD BE ELIGIBLE FOR ENDOVASCULAR ANEURYSM REPAIR (EVAR) AND TO EXAMINE THE MAJOR DETERMINANTS FOR SUITABILITY OF EVAR WITH THE CURRENTLY AVAILABLE INDICATIONS. WE RETROSPECTIVELY REVIEWED 3-D RECONSTRUCTED COMPUTED TOMOGRAPHY ANGIOGRAPHY OF 88 PATIENTS WITH AN ATHEROSCLEROTIC AAA WHO UNDERWENT OPEN REPAIR OR EVAR BETWEEN OCTOBER 2003 AND OCTOBER 2010 AT THE CARDIOVASCULAR CENTER, (B)(6) HOSPITAL. OF THE 88 PATIENTS, 71 (80.7%) WERE TREATED WITH OPEN REPAIR AND 17 (19.3%) WERE TREATED WITH EVAR. THE RATE OF MINOR COMPLICATIONS, POST PROCEDURAL INTENSIVE CARE UNIT STAY, AND TOTAL HOSPITAL STAY WERE SIGNIFICANTLY LOWER IN THE EVAR GROUP. WHEN THE SUITABILITY OF EVAR WAS REEVALUATED USING MORPHOLOGIC CRITERIA, A TOTAL OF 33 (37.5%) PATIENTS WERE CONSIDERED ELIGIBLE FOR EVAR. MULTIVARIATE ANALYSIS REVEALED THAT PROXIMAL NECK LENGTH, PROXIMAL NECK ANGLE, AND ANEURISMAL SAC SIZE WERE INDEPENDENT DETERMINANTS FOR SUITABILITY OF EVAR. TAKING INTO ACCOUNT THE INCREASED CLINICAL EXPERIENCE AND THE AVAILABILITY OF NEW DEVICES, EVAR WOULD BE APPLICABLE IN ABOUT 40% OF ATHEROSCLEROTIC AAA CASES IN THIS SERIES OF KOREAN PATIENTS. ACCURATE IDENTIFICATION OF CANDIDATES FOR EVAR BY DETAILED PREOPERATIVE EVALUATION, ESPECIALLY FOR MORPHOLOGIC CHARACTERISTICS, IS ESSENTIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147065 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention