BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

    MDR report key: 8456210 · Received March 27, 2019

    Report

    Report Number
    2953200-2019-00413
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    October 24, 2018
    Report Date
    March 27, 2019
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; MULTICENTER EXPERIENCE WITH ENDOVASCULAR TREATMENT OF AORTIC COARCTATION IN ADULTS. YOUNG ERBEN, GUSTAVO S. ODERICH, HENCE J. M. VERHAGEN, MAARTEN WITSENBURG, ALLARD T. VAN DEN HOVEN, EIKE S. DEBUS, MD, TILO KÖLBEL, MD, FRANK R. ARKO III, GIOVANNI B. TORSELLO, GIOVANNI F. TORSELLO,PETER F. LAWRENCE, MICHAEL P. HARLANDER-LOCKE, MPHMICHAEL BACHARACH, MD, WILLIAM D. JORDAN JR, MARK K. ESKANDARI, AND DONALD J. HAGLER. J VASC SURG 2019 (69) ISSUE 3 HTTPS://DOI.ORG/10.1016/J.JVS.2018.06.209. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR ENDOVASCULAR TREATMENT OF AORTIC COARCTATIONS BETWEEN 1999 AND 2015. THE FOLLOWING EVENTS WERE REPORTED: SERIOUS INJURY: RUPTURE EMBOLISM HEMORRHAGE DISSECTION LUMBAR HEADACHE CARDIAC ARREST INFECTION ISCHEMIA RE-INTERVENTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249725 SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention