BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER DUCT OCCLUDER

    MDR report key: 3852249 · Received June 5, 2014

    Report

    Report Number
    2135147-2014-00053
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 22, 2014
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MAE
    PMA / PMN Number
    P020024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE BECAUSE THE ADO AND 6F AMPLATZER DELIVERY SYSTEM WERE NOT RETURNED FOR ANALYSIS; HOWEVER, REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE ADO MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. (THE DELIVERY SYSTEM'S LOT NUMBER WAS DISCARDED, THEREFORE, ITS DEVICE HISTORY RECORD COULD NOT BE REVIEWED.) THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN. USER FACILITY/IMPORTER NUMBER: (B)(4).

    Description of Event or Problem · 1

    AN 8/6MM AMPLATZER DUCT OCCLUDER (ADO) WAS DEPLOYED INTO THE PATENT DUCTUS ARTERIOSIS (PDA); HOWEVER, THE DEVICE POSITION WAS UNSATISFACTORY AND THE RETENTION SKIRT APPEARED TOO WIDE BUT THE ADO COULD NOT BE RETRACTED INTO A 6F AMPLATZER TORQVUE 180 DELIVERY SYSTEM SHEATH TO REPOSITION AND RESHAPE IT. INSTEAD, THE RETENTION SKIRT WAS PUSHED AGAINST THE POSTERIOR WALL OF THE AORTIC ARCH TO FLATTEN THE DEVICE WHICH WAS REDEPLOYED INTO THE PDA. AFTER VERIFYING POSITION ON ANGIOGRAPHY, THE ADO WAS RELEASED BUT CHANGED POSITION WITHIN THE PDA RESULTING IN A RESIDUAL SHUNT. AFTER CONTINUING TO MONITOR THE PATIENT'S STATUS, THE AORTIC ARCH WAS DISTORTED BY THE RETENTION SKIRT AND THE DECISION WAS MADE TO REMOVE THE DEVICE. THE ADO WAS EXPLANTED THE SAME DAY AND THE PDA WAS LIGATED. THE PATIENT WAS CLINICALLY STABLE THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329547 AMPLATZER DUCT OCCLUDER CARDIAC OCCLUSION DEVICE MAE AGA MEDICAL CORPORATION 9-PDA-005 4518547

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Required Intervention 9-ITV06F180/80