BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 7780735 · Received August 14, 2018

    Report

    Report Number
    2135147-2018-00101
    Event Type
    Death
    Date Received
    August 14, 2018
    Date of Event
    July 17, 2018
    Report Date
    August 14, 2018
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    05415067019318
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT OF EROSION, PERICARDIAL EFFUSION, TAMPONADE AND PATIENT DEATH WAS REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PER THE WARNINGS SECTION OF THE INSTRUCTIONS FOR USE (ARTEN600039487), "PATIENTS WITH A RETRO-AORTIC RIM OF LESS THAN 5 MM IN ANY ECHOCARDIOGRAPHIC PLANE, OR PATIENTS IN WHOM THE DEVICE PHYSICALLY IMPINGES ON (I.E. INDENTS OR DISTORTS) THE AORTIC ROOT, MAY BE AT INCREASED RISK OF EROSION." "ABSENCE OF THE ANTERIOR SUPERIOR (AORTIC) RIM AND DEVICE OVERSIZING MAY BE RELATED TO THE CAUSATION OF EROSION DUE TO THE INCREASED LIKELIHOOD OF DEVICE-TISSUE CONTACT IN THE DYNAMIC ANATOMIC AREA AT HIGHEST RISK FOR EROSION."

    Description of Event or Problem · 1

    ON (B)(6) 2018, A 26 MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. AFTER IMPLANT, THE PATIENT COMPLAINED OF CHEST PAIN AND ECHOCARDIOGRAM SHOWED A SMALL TO MODERATE PERICARDIAL EFFUSION WITH THE DEVICE STILL IN GOOD POSITION. BEDSIDE PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS INTUBATED. THE PERICARDIOCENTESIS REVEALED FRANK BLOOD CLOTS AND THE PATIENT QUICKLY DECOMPENSATE AND CPR WAS ADMINISTRATED. THE PATIENT REQUIRED CPR WHILE TRANSFERRED TO THE OR WHERE AN EMERGENCY STERNOTOMY WAS PERFORMED. THE PATIENT WAS PLACED ON CARDIAC BYPASS, AND CARDIAC TAMPONADE PHYSIOLOGY WAS NOTED. IN THE OPERATING ROOM (OR), TWO HOLES WERE DEMONSTRATED IN THE AORTIC ROOT AND ROOF OF THE RIGHT ATRIUM. BOTH WERE SURGICALLY CLOSED. DUE TO THE CLINICAL CONDITION THE PATIENT WAS TRANSFERRED TO A REGIONAL MEDICAL CENTER FOR ECMO. UPON ARRIVAL AT THE SECOND HOSPITAL ON (B)(6) 2018, THE PATIENT WAS TAKEN TO THE OR WHERE THE DEVICE WAS NOTED TO BE IN GOOD POSITION HOWEVER THE DISK HAD LEFT AN INDENTATION IN THE ATRIA AND HAD RUBBED THROUGH THE ROOF OF THE ATRIA AT THE JUNCTION OF THE AORTIC ROOF AND RIGHT ATRIA. THE DEVICE WAS REMOVED. THE PATIENT¿S HEART SLOWLY RECOVERED WITH THE USE OF ECMO, HOWEVER THE HEAD AND ABDOMINAL CT SHOWED THE PATIENT HAD INSURMOUNTABLE INJURIES AND CARE WAS WITHDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621970 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-026 5570863 05415067019318

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Death| R