BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 635193 · Received September 14, 2005

    Report

    Report Number
    2135147-2005-00027
    Event Type
    Injury
    Date Received
    September 14, 2005
    Date of Event
    June 1, 2004
    Report Date
    September 14, 2005
    Manufacturer
    AGA MEDICAL CORP.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS REPORTED IN THE PUBLICATION OF CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 65:588-592 (2005): THE PATIENT PRESENTED WITH PROGRESSIVE LIMITING EXERTIONAL DYSPNEA. THEY HAVE CHRONIC TOBACCO USE AND REACTIVE AIRWAY DISEASE. THERE WAS A KNOWN SECONDUM ASD, WHICH WAS DEFINED BY CATHETERIZATION, 10 YEARS PREVIOUSLY. THE CORONARY ARTERIES WERE NORMAL AND THERE WA A LEFT-TO-RIGHT SHUNT RATION OF 2.3:1 AT THIS TIME. THEY HAD MODERATE PULMONARY HYPERTENSION. ECHOCARDIOGRAPHY ON THIS ADMISSION SHOWED A 17MM SECUNDUM ASD AND SUGGESTED A PULMONARY ARTERY SYSTOLIC PRESSURE OF 60MM HG. RIGHT HEART CATHETERIZATION REVEALED A PULMONARY ARTERY PRESSURE OF 45/18 MM HG AND THE PULMONARY-TO-SYSTEMIC FLOW RATIO WAS CALCULATED TO BE 2.8:1 LITER/MIN. UNDER INTERCARDIAC ECHOCARDIOGRAPHIC (ICE) GUIDANCE, THE 25MM SIZING BALLOON WAS POSITIONED ACROSS THE DEFECT. IT WAS INFLATED TO 22MM DIAMETER, AT WHICH POINT THE SHUNT FLOW CEASED. A 24MM AMPLATZER DEVICE WAS CHOSEN AND DELIVERED TO POSITION. THE LEFT ATRIAL DISK WAS PULLED INTO THE ATRIAL DEFECT, AND THE RIGHT ATRIAL DISK WAS THEN RELEASED. VIGOROUS FORWARD AND BACKWARD MOVEMENT ON THE DELIVERY CABLE COULD NOT DISPLACE THE DEVICE. THERE WAS SOME FLOW VISIBLE WITHIN THE TWO DISKS OF THE DEVICE, WHICH IS THE USUAL APPEARANCE. THE ICE POSITIONING WAS CORRECT, AS WAS THE ANGIOGRAPHIC IMAGING. ONCE POSITIONING WAS CONFIRMED, THE DELIVERY CABLE WAS DISCONNECTED FROM THE DEVICE AND REMOVED. CONTRAST INJECTION IN THE RIGHT ATRIUM WAS PERFORMED, SHOWING PROPER POSITIONING OF THE DEVICE WITH OUTLINE OF THE RIGHT ATRIAL CONTOUR. THE PATIENT HAD NO SYMPTOMS, HOWEVER, THE FOLLOWING MORNING A ROUTINE ECHOCARDIOGRAM AND CHEST X-RAY WERE DONE. THESE IMAGES SHOWED THAT THE DEVICE HAD EMBOLIZED TO THE PULMONARY ARTERY BEHIND THE AORTA. THE DEVICE WAS POSITIONED SIDEWAYS IN THE PULMONARY ARTERY WITH NO OBVIOUS ACCESS TO THE RIGHT ATRIAL SCREW CONNECTOR. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR SURGICAL RETRIEVAL OF THE DEVICE AND REPAIR OF THE ASD. THE POSTOPERATIVE RECOVERY WAS COMPLICATED BY ATRIAL FIBRILLATION AND THE NEED FOR PERMANENT CARDIAC PACING FOR HIGH-DEGREE HEART BLOCK. THEY ULTIMATELY RECOVERED AND WAS DISCHARGED HOME IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORP. 9-ASD-024 M02I25-01

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention