BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGA MEDICAL CORPORATION

    MDR report key: 1531935 · Received November 10, 2009

    Report

    Report Number
    MW5013510
    Event Type
    Injury
    Date Received
    November 10, 2009
    Date of Event
    February 7, 2009
    Report Date
    November 10, 2009
    Product Code
    MLV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PT, WITH HISTORY OF VSD, PDA AND ASD, REFERRED TO THE FACILITY FOR ELECTIVE PERCUTANEOUS ASD OCCLUDER DEVICE -2/6-. UNEVENTFUL PROCEDURE, AND WAS PREPARING TO GO HOME WHEN HE BEGAN COMPLAINING OF SUDDEN, INTENSE CHEST PAIN. AN ECHOCARDIOGRAM JUST 1 HR TO DISCHARGE, SHOWED GOOD DEVICE PLACEMENT AND NO PERICARDIAL EFFUSION. A STAT REPEAT ECHOCARDIOGRAM SHOWED A RAPIDLY ACCUMULATING PERICARDIAL EFFUSION WITH SOME EARLY SIGNS OF TAMPONADE. THERE WAS NO EVIDENCE OF DEVICE EMBOLIZATION, BUT SOME SUGGESTION OF EROSION THROUGH THE MYOCARDIUM. HE WAS TRANSFERRED TO THE CICU, WHERE HE WAS INTUBATED, SEDATED, AND INVASIVE LINES WERE PLACED FOR MONITORING. SUBSEQUENT REPEAT ECHOES SHOWED A GRADUALLY INCREASING EFFUSION. INOTROPIC SUPPORT -DOPAMINE- WAS STARTED, IN ADDITION TO MULTIPLE FLUID BOLUSES TO MAINTAIN ADEQUATE BLOOD PRESSURE. URGENT CT SURGICAL CONSULTATION WAS OBTAINED, AND IT WAS AGREED THAT EXPLORATORY MEDIAN STERNOTOMY WITH REPAIR OF POSSIBLE MYOCARDIAL PERFORATION WAS WARRANTED. PT UNDERWENT PERICARDIAL PATCH CLOSURE OF ASD, REMOVAL OF ASD DEVICE, AND REPAIR OF RIGHT ATRIUM AND AORTA. TOLERATED OR AS WELL AS COULD BE EXPECTED, AND RETURNED TO CICU IN STABLE CONDITION. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: ASD CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER MLV M08A31-04

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Congenital Anomaly| H| L| S