BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1062526 · Received June 20, 2008

    Report

    Report Number
    2135147-2008-00049
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    November 1, 2007
    Report Date
    June 20, 2008
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS FROM AN ARTICLE PUBLISHED IN THE JOURNAL OF INTERVENTIONAL CARDIOLOGY; TRANSESOPHAGEAL ECHOCARDIOGRAPHY AND INTRACARDIAC ECHOCARDIOGRAPHY DIFFERENTLY PREDICT POTENTIAL TECHNICAL CHALLENGES OR FAILURES OF INTERATRIAL SHUNTS CATHETER-BASED CLOSURE: ONE PATIENT WITH AN EMBROYONIC MEMBRANE UNDERWENT APPARENTLY SUCCESSFUL CLOSURE BUT ONE MONTH LATER, TEE REVEALED THAT THE DEVICE HAD BEEN DEVIATED BY THE EMBRYONIC MEMBRANE FROM THE TRUE RIM AND IT WAS DECIDED TO REMOVE IT SURGICALLY. CLOSURE WAS ATTEMPTED ON ANOTHER PATIENT WITH AN ASD AND FLOPPY RIMS, BUT THE DEVICE WAS UNSTABLE AND RETRACTED PRIOR TO SURGICAL CLOSURE. THE ARTICLE SITED USING PFO, CRIBRIFORM AND ASD DEVICES. IT IS UNKNOWN AS TO WHICH DEVICES EMBOLIZED. AGA MEDICAL CONTACTED THE AUTHOR OF THIS ARTICLE AND NO ADDITIONAL INFORMATION WILL BE PROVIDED REGARDING THESE EVENTS. THE ARTICLE IS ATTACHED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention