BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 757563 · Received September 1, 2006

    Report

    Report Number
    2135147-2006-00057
    Event Type
    Injury
    Date Received
    September 1, 2006
    Date of Event
    July 14, 2006
    Report Date
    September 1, 2006
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY SYSTEM INVOLVED IN THIS INCIDENT WAS NOT RETURNED TO AGA MEDICAL; IT WAS THROWN AWAY AT THE HOSPITAL. THE LOT NUMBER WAS NOT PROVIDED. DEVICE EXAMINATION BY AGA MEDICAL'S SENIOR RESEARCH AND DEVELOPMENT SCIENTIST FOUND NO ABNORMALITIES. INVESTIGATION VERIFIED THE DEVICE MET DIMENSIONAL SPECIFICATIONS. REVIEW OF THE CATH LAB REPORT BY AGA MEDICAL'S SENIOR RESEARCH AND DEVELOPMENT SCIENTIST WAS INCONCLUSIVE, DUE TO THE LIMITED INFORMATION RECEIVED. (SEE ATTACHMENT 3). DEVICE EMBOLIZATION WITH SURGICAL REMOVAL IS A KNOWN ADVERSE EVENT (IFU SECTION 6.3). PHYSICIANS MUST BE PREPARED TO DEAL WITH URGENT SITUATIONS, WHICH REQUIRE REMOVAL OF EMBOLIZED DEVICES THAT RESULT IN CRITICAL HEMODYNAMIC COMPROMISE. THIS INCLUDES THE AVAILABILITY OF AN ON-SITE SURGEON (IFU SECTION 4.3).

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT WHO HAD AN ASD, THE PHYSICIAN SELECTED AN 18MM ASD DEVICE AFTER MEASURING THE DEFECT THROUGH BOTH TEE AND SIZING BALLOON. YET, THE DEVICE WAS INVOLUNTARILY DETACHED FROM THE CABLE DURING POSITIONING, EVEN THOUGH THE DEVICE WAS NOT BEING PUSHED OR ROTATED. THEREFORE, THE PATIENT WAS SENT TO OR FOR SURGICAL REMOVAL OF THE ASD DEVICE AND SURGICAL REPAIR OF THE DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-018 M05K20-35

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention AMPLATZER 9-DEL-8F-45/80 (LOT NUMBER UNK)