BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 19382495 · Received May 23, 2024

    Report

    Report Number
    2135147-2024-02342
    Event Type
    Injury
    Date Received
    May 23, 2024
    Date of Event
    April 28, 2024
    Report Date
    July 12, 2024
    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
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF CHEST PAIN, MODERATE PERICARDIAL EFFUSION CIRCUMFERENTIAL TO HEART AND CARDIAC TAMPONADE AFTER OVER A MONTH OF AMULET IMPLANT WAS REPORTED. INFORMATION FROM FIELD INDICATED THAT A CARDIAC WINDOW PROCEDURE AND PERICARDIOCENTESIS WAS PERFORMED, AND 800 CC OF FLUID WAS DRAINED. PERICARDIAL EFFUSION RESOLVED AFTER THE DRAIN. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE. FURTHERMORE, IMAGING PROVIDED WAS REVIEWED: A TTE TIMED 3:45PM APR 28, 2024 CONFIRMED A CIRCUMFERENTIAL PE WITH MAXIMUM DIMENSIONS OF 15.7MM (ANTERIORLY) AND 21.6MM (POSTERIORLY). AN APICAL 4 CHAMBER VIEW SHOWS DECREASED RV DIASTOLIC FILLING DISTALLY, BUT OVERT TAMPONADE PHYSIOLOGY IS NOT OBSERVED. THE COMPLAINT FORM STATES THAT DRAINAGE OF 800CC WAS PERFORMED. IN THIS REVIEWER'S OPINION, THE PRESENCE OF A 1.4CM PRE-PROCEDURE POSTERO-LATERAL PERICARDIAL EFFUSION SHOULD GIVE PAUSE TO THE IMPLANTER REGARDING WHETHER THE AMULET IMPLANT SHOULD BE ATTEMPTED. IF THE PRE-EXISTING EFFUSION'S ETIOLOGY IS UNCLEAR BUT PERHAPS HEMORRHAGIC, DELIVERY OF INTRAPROCEDURAL HEPARIN COULD EXACERBATE THE EFFUSION AND INCREASE RISK TO PATIENT OF HEMODYNAMIC COLLAPSE. THAT SAID, THE IMMEDIATE POST IMPLANT TTE SHOWS NO PROGRESSION OF EXISITING PE AT DISCHARGE. SINCE NO IMAGING OF THE PROCEDURAL STEPS AFTER DS INSERTION ARE PROVIDED, NO COMMENT CAN BE MADE ABOUT THE IMPLANT'S TECHNICAL FACTORS POSSIBLE CONTRIBUTION TO THE WORSENING OF THE PE. HOWEVER, THE ED TTE GENERATED 51 DAYS POST IMPLANT CLEARLY SHOWS A LARGER, CIRCUMFERENTIAL EFFUSION. THE UNANSWERABLE QUESTION IS WHETHER THE AMULET IMPLANT CONTRIBUTED TO THIS PE PROGRESSION OR WAS THE UNDERLYING FACTOR(S) THAT INITIALLY GENERATED THE PE ALSO RESPONSIBLE FOR ITS PROGRESSION.

    Additional Manufacturer Narrative · 0

    THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT ON (B)(6) 2024, A 20MM AMULET LEFT ATRIAL APPENDAGE OCCLUDER (LOT: 8941023) WAS IMPLANTED SUCCESSFULLY UTILIZING A 14F AMULET STEERABLE GUIDE CATHETER. AFTER PERICARDIOCENTESIS, ANTI-THROMBOTIC REGIMEN ADJUSTED TO PATIENT JUST TAKING ASPIRIN. PATIENT RESUMED ASPIRIN 81 MG THE NEXT DAY AFTER PERICARDIOCENTESIS. PATIENT WAS REPORTED TO BE DISCHARGED.

    Description of Event or Problem · 0

    (B)(4) ADVANCE LAA PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 20MM AMULET LEFT ATRIAL APPENDAGE OCCLUDER (LOT: UNKNOWN) WAS IMPLANTED SUCCESSFULLY UTILIZING A 14F AMULET STEERABLE GUIDE CATHETER. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PAIN. AN ECHOCARDIOGRAM WAS PERFORMED WHERE MODERATE PERICARDIAL EFFUSION WAS OBSERVED CIRCUMFERENTIAL TO THE HEART. CARDIAC TAMPONADE WAS OBSERVED AS WELL. A CARDIAC WINDOW PROCEDURE WAS PERFORMED AND PERICARDIOCENTESIS, WHERE 800 CC OF FLUID WAS DRAINED. PERICARDIAL EFFUSION RESOLVED AFTER THE DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583363 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 8941023 00811806013473

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Unknown Hospitalization| R| L