BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 4169287 · Received October 14, 2014

    Report

    Report Number
    2135147-2014-00101
    Event Type
    Death
    Date Received
    October 14, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 24, 2014
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    PP000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REVIEWED BY THE ST. JUDE MEDICAL EROSION BOARD AND CONFIRMED THAT EROSION OCCURRED.

    Additional Manufacturer Narrative · 1

    (B)(4). SJM COULD NOT EVALUATE THE ASO INVOLVED IN THIS INCIDENT SINCE IT WAS NOT RETURNED TO US. THE DEVICE HISTORY RECORD FOR THIS PRODUCT WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES.

    Description of Event or Problem · 1

    A LARGE ATRIAL SEPTAL DEFECT (ASD) WITH NO RETROAORTIC RIM AND A FLOPPY POSTERIOR RIM WAS CLOSED WITH A 28MM AMPLATZER SEPTAL OCCLUDER (ASO) ON (B)(6) 2014. THE PATIENT HAD ATYPICAL CHEST PAIN (WITH SKIN SENSITIVITY) HOURS AFTER THE PROCEDURE WHICH GRADUALLY SUBSIDED THE DAY AFTER THE PROCEDURE. REPEATED ECHOCARDIOGRAM SCANS SHOWED NO PERICARDIAL EFFUSION AND THE ASO IN GOOD POSITION, INCLUDING TOWARDS THE AORTA. SEVERE MIGRAINE WAS PRESENT TWO DAYS AFTER THE PROCEDURE AND THE PATIENT WAS DISCHARGED. RECURRENT CHEST PAIN OCCURRED THREE DAYS AFTER THE PROCEDURE BUT THERE WAS NO CONTACT WITH THE MEDICAL TEAM. FOUR DAYS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED SUDDEN ONSET OF SEVERE CHEST PAIN AND SEIZURES AT HOME. AN EMERGENCY ECHOCARDIOGRAM THIRTY MINUTES LATER SHOWED CARDIAC TAMPONADE AND CIRCULATORY COLLAPSE. HEART MASSAGE AND SURGICAL PERICARDIOTOMY WITH REMOVAL OF PERICARDIAL BLOOD WAS PERFORMED. THE PATIENT WAS THEN TRANSPORTED TO ANOTHER HOSPITAL FOR CARDIOPULMONARY BYPASS SURGERY TWO HOURS LATER WHERE THE ASO WAS REMOVED AND THE DEFECT WAS PATCHED. ACCORDING TO THE CARDIAC SURGEON, THE ASO ERODED THE AORTIC WALL. THE PATIENT SUSTAINED SEVERE BRAIN DAMAGE AND DIED IN THE INTENSIVE CARE UNIT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651390 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-028 1204241352

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death| H| R