BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER VASCULAR PLUG

    MDR report key: 14493544 · Received May 25, 2022

    Report

    Report Number
    2135147-2022-00311
    Event Type
    Injury
    Date Received
    May 25, 2022
    Report Date
    May 24, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    KRD
    UDI-DI
    00811806011455
    PMA / PMN Number
    K031810
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, AN AMPLATZER VASCULAR PLUG MIGRATED ONE MINUTE AFTER PLACEMENT AND WAS REMOVED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR ADDITIONAL INFORMATION WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    AN ARTICLE FROM THE MEDICAL CONFERENCE ABSTRACT MAGAZINE FOR (B)(6) SOCIETY OF CONGENITAL INTERVENTIONAL CARDIOLOGY, WAS REVIEWED. THE RESEARCH ARTICLE PRESENTS A CASE OF A (B)(6) FEMALE WHO HAD A NON -ABBOTT DEVICE IMPLANTED IN THE VENOUS DUCT AT BIRTH AND HAD A HISTORY OF ASPLENIA, SINGLE VENTRICLE, AORTIC STENOSIS, COARCTATION OF AORTA AND COMPLICATED BY TOTAL ANOMALOUS PULMONARY VENOUS CONNECTION (TAPVC) IN ORDER TO POSTPONE THE TIMING OF SURGERY. BILATERAL PULMONARY ARTERIAL BANDING WAS PERFORMED WHEN THE PATIENT WAS (B)(6). TAPVC REPAIR WAS CONDUCTED AT 3 MONTH AFTER THE BIRTH. TWO WEEK AFTER, NORWOOD SURGERY AND GLENN SURGERY WERE PERFORMED. RESIDUAL BLOOD FLOW WAS CONFIRMED WITHIN THE STENT. DECREASING SATURATION OF OXYGEN WAS OBSERVED DUE TO HEPATOPULMONARY SYNDROME. PRIOR TO FONTAN SURGERY, IT WAS DECIDED TO EMBOLIZE THE BLOOD FLOW INSIDE THE STENT BY AMPLATZER VASCULAR PLUG (AVP)WHEN THE PATIENT WAS (B)(6). A 6MM AMPLATZER VASCULAR PLUG WAS IMPLANTED, ONE MINUTE AFTER, THE DEVICE MIGRATED INTO THE DESCENDING ARTERY WAS REMOVED BY A NON -ABBOTT DEVICE. THE VENOUS DUCT WAS SURGICALLY SEMI-SUTURED AND ACHIEVED COMPLETE CLOSURE SPONTANEOUSLY. AFTER THAT, FONTAN SURGERY WAS UNDERGONE AND HEPATOPULMONARY SYNDROME BECAME IMPROVED. [ THE AUTHOR AND CORRESPONDING AUTHOR OF THIS ARTICLE IS ONO, HIROSHI, MD 157-8535 2-10-1 OKURA, SETAGAYA-KU, TOKYO TEL: 03-3416-0181 FAX: 03-3416-2222]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2266556 AMPLATZER VASCULAR PLUG DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD ABBOTT MEDICAL 9-PLUG-006 00811806011455

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Female Required Intervention