BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER VASCULAR PLUG

    MDR report key: 1404403 · Received June 22, 2009

    Report

    Report Number
    2135147-2009-00050
    Event Type
    Injury
    Date Received
    June 22, 2009
    Date of Event
    December 1, 2007
    Report Date
    June 17, 2009
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    KRD
    PMA / PMN Number
    K031810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGA MEDICAL HAS NOT RECEIVED ANY ADDITIONAL INFORMATION REGARDING THIS EVENT, INCLUDING PATIENT AND DEVICE INFORMATION.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE "PREOPERATIVE PORTAL VEIN EMBOLIZATION (PVE) USING AN AMPLATZER VASCULAR PLUG (AVP)" REPORTED THE FOLLOWING ADVERSE EVENT(S): PATIENT #1 (A) - ONE PATIENT WHO UNDERWENT AVP DEPLOYMENT IN THE FIRST-ORDER RIGHT PV COMPLAINED OF SEVERE ABDOMINAL PAIN AFTER PVE, AND LIVER ENZYME LEVELS WERE MARKEDLY INCREASED AT 6 H AFTER PVE. CT 12 H AFTER PVE REVEALED SEGMENTAL INFARCTION IN THE RIGHT LOBE OF THE LIVER WITH EXTENSIVE THROMBOSIS IN THE SUPERIOR MESENTERIC VEIN, MAIN AND RIGHT PV, AND PROXIMAL LEFT PV DUE TO PROTRUSION OF THE AVP INTO THE MAIN PV. THE PATIENT UNDERWENT EMERGENCY SURGICAL REMOVAL OF THE AVP, THROMBECTOMY, AND LIGATION OF THE RIGHT PV. PATIENT #2 (B) - RECANALIZATION OCCURRED IN THE PV THAT HAD BEEN EMBOLIZED USING THE AVP; FOLLOW-UP CT OF THIS PATIENT CONFIRMED THAT THE AVP WAS DEPLOYED AT THE ANTERIOR PV WITH PARTIAL COVERING OF THE POSTERIOR PV. REFER TO THE ARTICLE FOR COMPLETE DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER VASCULAR PLUG ARTERIAL EMBOLIZATION DEVICE KRD AGA MEDICAL CORPORATION 9-PLUG-000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention