BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER® SEPTAL OCCLUDER

    MDR report key: 2240786 · Received September 9, 2011

    Report

    Report Number
    2135147-2011-00120
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    January 1, 2010
    Report Date
    September 8, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE ARTICLE "DEVICE CLOSURE OF ATRIAL SEPTAL DEFECT: MEDIUM-TERM OUTCOME WITH SPECIAL REFERENCE TO COMPLICATIONS" FROM THE JOURNAL CARDIOLOGY IN THE YOUNG REPORTED THE FOLLOWING EVENTS: EMBOLIZATION IN FOUR (4) PATIENTS AND WAS ASSOCIATED WITH SHORT INTERIOR CAVA VEIN MARGIN. IN TWO (2) OF THE PATIENTS, THE DEVICE EMBOLIZED IMMEDIATELY AFTER DEPLOYMENT. THE DEVICES WERE PERCUTANEOUSLY RETRIEVED. A LARGER DEVICE WAS IMPLANTED IN ONE PATIENT AND THE OTHER UNDERWENT SURGICAL CLOSURE. IN OTHER TWO (2) PATIENTS, THE DEVICES EMBOLIZED WITHIN 24 HOURS AND WERE SURGICALLY REMOVED. ONE PATIENT WAS A (B)(6) FEMALE AND A 9-ASD-020 WAS IMPLANTED IN AN 18MM DEFECT. THE SECOND PATIENT WAS (B)(6) IMPLANTED WITH A 26MM ASO IN A 23MM ASD. EARLY COMPLICATIONS INCLUDED PERICARDIAL EFFUSION, 2:1 HEART BLOCK, INFECTIVE ENDOCARDITIS. EIGHT (8) PATIENTS REPORTED MIGRAINE WITH AURA. TWO (2) PATIENTS DEVELOPED MILD AORTIC REGURGITATION WHICH CORRELATED WITH A DEVICE-TO-DEFECT RATION OF >1.3:1. THERE WERE NO EROSIONS, LATE EMBOLIZATIONS, OR THROMBOEMBOLISM. ATRIAL FIBRILLATION OCCURRED WITH THREE (3) ADULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention