BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 19297442 · Received May 13, 2024

    Report

    Report Number
    2135147-2024-02137
    Event Type
    Injury
    Date Received
    May 13, 2024
    Date of Event
    April 22, 2024
    Report Date
    June 24, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013497
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS THE DEVICE WAS REPORTEDLY DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. MEDICAL DEVICE PROBLEM CODE: 2017- IMPROPER OR INCORRECT PROCEDURE OR METHOD.

    Additional Manufacturer Narrative · 0

    AN EVENT OF PERICARDIAL EFFUSION AND CARDIAC TAMPONADE AND DEVICE EMBOLIZATION IN LEFT VENTRICLE WAS REPORTED. IT WAS ALSO REPORTED THAT WHEN BEING EXTUBATED, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AND CARDIOPULMONARY RESUSCITATION WAS STARTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE 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. INFORMATION FROM FIELD INDICATED THAT THE SAME DELIVERY SYSTEM WAS USED WITH THE 28 MM AMULET AND THE DEVICE WAS IMPLANTED SUCCESSFULLY AFTER ONE PARTIAL RECAPTURE. PLEASE NOTE THAT PER THE INSTRUCTIONS FOR USE, "IF THE DEVICE IS RETRACTED FARTHER THAN THE RADIOPAQUE MARKERS (FULLY RECAPTURED), THE DEVICE AND THE SHEATH MUST BOTH BE REMOVED AND REPLACED. FAILURE TO REPLACE BOTH THE DEVICE AND THE SHEATH MAY RESULT IN SHEATH AND/OR DEVICE MALFUNCTION." BASED ON INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER REPORTED PERICARDIAL EFFUSION COULD POSSIBLY BE RELATED TO MULTIPLE MANIPULATION OF 28 MM AMULET DEVICE BEFORE IMPLANTING AN 25 MM AMULET DEVICE. THE EMBOLIZED DEVICE WAS REMOVED THROUGH SURGICAL INTERVENTION AND THE LAA WAS LIGATED. A PUNCTURE WAS OBSERVED TO THE LEFT PULMONARY ARTERY NEAR THE AMULET STABILIZING WIRES AND WAS SUTURED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER (LOT: 8894664) WAS CHOSEN FOR IMPLANTATION UTILIZING 14F AMPLATZER TORQVUE DELIVERY SYSTEM. HEPARIN WAS ADMINISTERED. THE 28MM AMULET WAS DETERMINED TO BE TOO LARGE AFTER MULTIPLE ATTEMPTS SO IT WAS SIZED DOWN TO A 25MM AMULET (LOT: 8704075). THERE WAS NO ISSUES WITH THE 28MM DEVICE BESIDES THE MIS-SIZE. THE SAME DELIVERY SYSTEM WAS USED WITH THE 25MM AMULET AND THE DEVICE WAS IMPLANTED SUCCESSFULLY AFTER ONE PARTIAL RECAPTURE. NO PERICARDIAL EFFUSION WAS NOTED POST IMPLANT VIA TRANSTHORACIC ECHOCARDIOGRAM (TTE). PROTAMINE WAS ADMINISTERED. WHEN BEING EXTUBATED, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AND CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED. TTE THEN CONFIRMED A PERICARDIAL EFFUSION AND CARDIAC TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED REMOVING 700CC OF FLUID. BLOOD WAS DARK RED. PATIENT WAS TRANSFERRED TO SURGERY AND OPEN HEART SURGERY WAS PERFORMED. THE AMULET WAS OBSERVED TO BE DISLODGED AND IN THE LEFT VENTRICLE, THOUGHT TO BE DUE TO CPR. THE DEVICE WAS REMOVED AND THE LAA WAS SURGICALLY LIGATED. PUNCTURE TO THE LEFT PULMONARY ARTERY WAS OBSERVED NEAR THE AMULET STABILIZING WIRES AND WAS SUTURED. THE PATIENT WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411483 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 8704075 00811806013497

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention| H| L