BEUDAMED
    FDA Adverse Event Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2103616 · Received May 26, 2011

    Report

    Report Number
    2135147-2011-00048
    Date Received
    May 26, 2011
    Date of Event
    February 12, 2009
    Report Date
    May 26, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGA MEDICAL COULD NOT EVALUATE THE ASO INVOLVED IN THIS INCIDENT SINCE IT REMAINS SUCCESSFULLY IMPLANTED. THE INDEPENDENT DSMB CONSIDERED THIS EVENT RESOLVED AND NOT RELATED TO THE DEVICE, DELIVERY SYSTEM OR PROCEDURE. THE AGA MEDICAL EROSION BOARD REVIEWED AND ADJUDICATED THIS EVENT ON (B)(6), 2011 AND DETERMINED NO EROSION OCCURRED.

    Description of Event or Problem · 1

    (B)(4). THE PATIENT IS A (B)(6) OLD MALE APPROXIMATELY (B)(6) WITH A DIAGNOSIS OF A SECUDUM ATRIAL SEPTAL DEFECT (ASD) AND SIGNS OF RIGHT HEART VOLUME OVERLOAD CONFIRMED BY TRANSTHORACIC ECHO (TTE). THE PATIENT HISTORY INCLUDES PRESENCE OF A STILL'S MURMUR AND ELECTROCARDIOGRAM (ECG) DEMONSTRATING INCOMPLETE RIGHT BUNDLE BRANCH BLOCK (RBBB). THE PATIENT WAS BROUGHT TO THE CARDIAC CATHETERIZATION (CATH) LAB ON (B)(6), 2009 WHERE A PRE-PROCEDURE TRANSESOPHAGEAL ECHO (TEE) WAS PERFORMED DEMONSTRATING A SMALL TO MODERATE SIZE ASD WITH MILD RIGHT VENTRICULAR (RV) DILATATION. THE AORTIC RIM WAS PRESENT, ATRIOVENTRICULAR (AV) VALVE, SUPERIOR VENA CAVA (SVC), AND INFERIOR VENA CAVA (IVC) RIMS WERE ALL SUFFICIENT, A NATIVE DIAMETER MEASUREMENT OF 8MM, STRETCHED TO 10MM VIA THE STOP FLOW TECHNIQUE. THE DISTANCE OF THE DEFECT TO THE CORONARY SINUS WAS 8MM, AV VALVES 9MM, AND RIGHT UPPER LOBE PULMONARY VEIN (RULPV) 10MM. THERE WAS NO EVIDENCE OF A PERICARDIAL EFFUSION. A 12MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS IMPLANTED WITHOUT COMPLICATION AND NO SHUNT ACROSS THE DEVICE WAS CONFIRMED. AN IMMEDIATE POST-PROCEDURE TEE DEMONSTRATED MILD RIGHT ATRIAL ENLARGEMENT, AND A TRACE PERICARDIAL EFFUSION. A PRE-DISCHARGE TTE SHOWED A TRACE PERICARDIAL EFFUSION. A PRE-DISCHARGE 2-VIEW CHEST RADIOGRAPH SHOWED NO EFFUSION AND THE PATIENT WAS DISCHARGED ON 40.5MG OF ASPIRIN EVERYDAY WITH NO INTERVENTION FOR THE PERICARDIAL EFFUSION. PATIENT WAS SEEN ONE MONTH POST-PROCEDURE ON (B)(6), 2009 AND UNDERWENT ANOTHER TEE THAT REPORTED "A SMALL PERICARDIAL EFFUSION, POSSIBLY INCREASED FROM PREVIOUS STUDY, THOUGH NO COMPARABLE VIEW". THE IMPLANTING PHYSICIAN DID NOT CONSIDER IT A PERICARDIAL EFFUSION AFTER REVIEWING THE TTE AND CONSIDERED THE EVENT RESOLVED. THE PATIENT WAS FOLLOWED FOR TWO YEARS WITH NO OTHER ADVERSE EVENTS RELATED TO THE EFFUSION OR CARDIOVASCULAR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-012 M07C07-12

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR