BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER VASCULAR PLUG II

    MDR report key: 7642129 · Received June 27, 2018

    Report

    Report Number
    2135147-2018-00078
    Event Type
    Injury
    Date Received
    June 27, 2018
    Date of Event
    May 23, 2018
    Report Date
    June 27, 2018
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    KRD
    UDI-DI
    00811806010441
    PMA / PMN Number
    K071125
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT OF A RESIDUAL SHUNT WAS REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, INFORMATION FROM THE FIELD INDICATED A RE-STERILIZED DEVICE WAS USED. PER THE INSTRUCTIONS FOR USE, 600539-003 VERSION A, "THIS DEVICE WAS STERILIZED WITH ETHYLENE OXIDE AND IS FOR SINGLE USE ONLY. DO NOT REUSE OR RESTERILIZE THIS DEVICE. ATTEMPTS TO RESTERILIZE THIS DEVICE CAN CAUSE A MALFUNCTION,INSUFFICIENT STERILIZATION, OR HARM TO THE PATIENT."

    Description of Event or Problem · 1

    ON (B)(6) 2018 A USER ELECTED TO USE A RE-STERILIZED 22MM AMPLATZER VASCULAR PLUG II. THE DEVICE WAS IMPLANTED AND AFTER IMPLANT, A RESIDUAL SHUNT REMAINED AND A 9MM AMPLATER DUCT OCCLUDER (LOT NUMBER: 6172614) WAS IMPLANTED TO DECREASE THE FLOW. ON (B)(6) 2018, A STEP IN THE FISTULA WAS OBSERVED, AND AGAIN THE USER ELECTED TO USE A RE-STERILIZED 12MM AMPLATZER VASCULAR PLUG II (LOT NUMBER: 5916435) AND COILS (MANUFACTURER UNKNOWN) WERE USED TO ADDRESS THE RESIDUAL SHUNTING. THE USER ELECTED TO USE RE-STERILIZED DEVICES EVEN THOUGH THE SITE HAD NEW DEVICES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482777 AMPLATZER VASCULAR PLUG II ARTERIAL EMBOLIZATION DEVICE KRD AGA MEDICAL CORPORATION 9-AVP2-022 6085243 00811806010441

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R