BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER AMULET

    MDR report key: 17386155 · Received July 24, 2023

    Report

    Report Number
    2135147-2023-03163
    Event Type
    Death
    Date Received
    July 24, 2023
    Date of Event
    June 29, 2023
    Report Date
    September 25, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013473
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    AN EVENT OF CHEST PAIN FOLLOWED BY PULSELESS ELECTRICAL ACTIVITY AND PATIENT DEATH WERE REPORTED. THE AMULET LOBE WAS NOTICED TO BE OFF AXIS DURING DEPLOYMENT AND THE DEVICE WAS PARTIALLY RECAPTURED AND WAS REDEPLOYED THREE TIMES. THE DEVICE POSITIONING AND STABILITY WERE CONFIRMED AND THE DEVICE WAS RELEASED WITH GOOD OCCLUSION. THERE WAS NO EFFUSION NOTED AFTER REMOVAL OF DELIVERY SYSTEM. 30-MINUTES AFTER PROCEDURE PATIENT WAS CODED FOR CHEST PAIN FOLLOWED BY PULSELESS ELECTRICAL ACTIVITY AND A CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. A PERICARDIOCENTESIS WAS PERFORMED AND 50ML WAS DRAINED FROM THE PATIENT. IT WAS REPORTED CPR WAS CONTINUED AND THE PATIENT WAS BROUGHT BACK TO LAB AND ADDITIONAL CPR WAS PERFORMED WHICH STABILIZED THE PATIENT. AN ADDITIONAL CPR WAS REQUIRED AND 3L OF BLOOD WAS DRAINED FROM THE PERICARDIAL TAP. THE PATIENT WAS EXPIRED THREE HOURS LATER. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS DUE TO CARDIAC TAMPONADE AND PULSELESS ELECTRICAL ACTIVITY. INFORMATION FROM FIELD INDICATED THAT THE PHYSICIAN BELIEVED THE PATIENT HAD AN EXTREMELY WEAK HEART AND POTENTIALLY EXPERIENCED A LARGE PERFORATION IN EITHER THE LEFT OR RIGHT VENTRICLE RELATED TO CPR PROCEDURE. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER INFORMATION FROM FIELD INDICATED THAT THE RESUSCITATIVE ACTIONS WERE BELIEVED TO BE THE CAUSE OF LATER EFFUSION AND TAMPONADE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.NA

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023, A 20MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT WITH A 14F UNKNOWN DELIVERY SYSTEM FOLLOWING A CONCOMITANT ATRIAL FIBRILLATION (AF) ABLATION PROCEDURE. IT WAS REPORTED THE PATIENT'S BASELINE RHYTHM WAS ATRIAL FIBRILLATION. DURING DEPLOYMENT OF THE AMULET, THE LOBE WAS NOTICED TO BE OFF AXIS AND THE DEVICE WAS PARTIALLY RECAPTURED. DURING THE SECOND DEPLOYMENT ATTEMPT AFTER CORRECTING DEPLOYMENT AXIS, THE DISC WAS DEPLOYMENT BUT DID NOT REACH THE COUMADIN RIDGE. THE DEVICE WAS PARTIALLY RECAPTURED A SECOND TIME AND REDEPLOYED MORE PROXIMAL IN THE LEFT ATRIAL APPENDAGE. THE DEVICE WAS REDEPLOYED A THIRD TIME AND DEVICE POSITIONING AND STABILITY WERE CONFIRMED. AFTER A TENSION TEST WAS PERFORMED, THE DEVICE WAS RELEASED WITH GOOD OCCLUSION AND THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. AN INTRACARDIAC ECHOCARDIOGRAPHY CATHETER WAS ADVANCED INTO THE RIGHT VENTRICLE AND CONFIRMED NO EFFUSION. IT WAS REPORTED THE PATIENT'S ACTIVATED CLOTTING TIME LEVELS WERE 250-350 SECONDS AND THEY WERE ADMINISTERED HEPARIN. PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION. IT WAS REPORTED 30 MINUTES FOLLOWING PROCEDURE, PATIENT WAS CODED FOR CHEST PAIN FOLLOWED BY PULSELESS ELECTRICAL ACTIVITY AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. A DECISION WAS MADE TO PERFORM A PERICARDIOCENTESIS AND 50ML WERE DRAINED FROM THE PATIENT. IT WAS REPORTED CPR WAS CONTINUED AND THE PATIENT WAS BROUGHT BACK TO LAB WHERE ADDITIONAL CPR WAS PERFORMED. THE PATIENT STABILIZED SHORTLY AND WAS ABOUT TO BE RETURNED TO RECOVERY BEFORE BEING CODED AGAIN. ADDITIONAL CPR WAS PERFORMED AND 3L OF BLOOD WAS DRAINED FROM THE PERICARDIAL TAP. IT WAS REPORTED THE PATIENT PASSED AWAY 3 HOURS AFTER THE INITIAL CODE WITH CAUSE OF DEATH DUE TO CARDIAC TAMPONADE AND PULSELESS ELECTRICAL ACTIVITY. THE PHYSICIAN BELIEVED THE PATIENT HAD AN EXTREMELY WEAK HEART AND POTENTIALLY EXPERIENCED A LARGE PERFORATION IN EITHER THE LEFT OR RIGHT VENTRICLE RELATED TO CPR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426181 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 8703934 00811806013473

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Death