BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1243364 · Received November 26, 2008

    Report

    Report Number
    2135147-2008-00108
    Event Type
    Injury
    Date Received
    November 26, 2008
    Date of Event
    September 19, 2008
    Report Date
    November 26, 2008
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE SINCE THE IMPLANT ECHOCARDIOGRAMS OR MEDICAL RECORDS WERE NOT PROVIDED TO AGA MEDICAL FOR REVIEW. ECHOCARDIOGRAMS ARE NEEDED TO CONFIRM SIZING AND EVALUATE OTHER PARAMETERS OF THE IMPLANT PROCEDURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AGA MEDICAL WILL FILE A SUPPLEMENT REPORT. THIS EVENT WAS INITIALLY REPORTED TO AGA MEDICAL IN 2008, AS A MIS-SIZED EVENT, AS THE INCIDENT DESCRIPTION INDICATED A 34MM WAS IMPLANTED AND UPON EXAMINATION A 36MM WAS DETERMINED TO BE THE APPROPRIATE SIZE. IN 2008, AGA MEDICAL RECEIVED A MEDICAL DEVICE ADVERSE EVENT REPORT THAT WAS SUBMITTED BY THE USER FACILITY, INDICATING THAT THE DEVICE HAD EMBOLIZED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED BY AGA MEDICAL; THEREFORE, WE ARE UNABLE TO PROVIDE THE PATIENT'S INFORMATION, A COMPLETE DESCRIPTION OF THE EVENT OR A COMPLETE INVESTIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AGA MEDICAL WILL PROVIDE A SUPPLEMENT REPORT. DEVICE DISCARDED

    Description of Event or Problem · 1

    TO SUMMARIZE THE EVENT, THE PATIENT WAS ADMITTED ELECTIVELY FOR AN ASD CLOSURE WITH AN AMPLATZER SEPTAL OCCLUDER. THE DEVICE ESCAPED RESULTING IN EMERGENT SURGERY FOR RETRIEVAL OF THE DEVICE AND CLOSURE OF THE ASD. THERE WERE NO INTRAOPERATIVE COMPLICATIONS AND THE PATIENT WAS WEANED FROM THE VENTILATOR WITHIN THREE HOURS. THE PATIENT DEVELOPED HYPOKALEMIA, ACUTE POST-OPERATIVE BLOOD LOSS THAT DID NOT REQUIRE REPLACEMENT, AND THROMBOCYTOPENIA THAT RESOLVED BY THE TIME OF DISCHARGE. THE PATIENT ALSO HAD POSTOPERATIVE ATELECTASIS WHICH WAS TREATED WITH VIGOROUS PULMONARY TOILET AND CARDIAC AMBULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-034 M08A31-08

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention