BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 21394980 · Received February 18, 2025

    Report

    Report Number
    2135147-2025-00793
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    January 23, 2025
    Report Date
    March 31, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013480
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A SMALL, CIRCUMFERENTIAL PERICARDIAL EFFUSION IN THE LEFT ATRIAL APPENDAGE (LAA). ALSO REPORTED THAT THE OCCLUDER WAS UNABLE TO BE SEATING COAXIALLY DESPITE BEING DEPLOYED IN THE SAME LOCATION AS THE FIRST OCCLUDER. INFORMATION FROM FIELD INDICATED THAT TWO OTHER AMULET DEVICES WERE ATTEMPTED TO BE DEPLOYED AND RE-CAPTURED BEFORE IMPLANTING 22 MM AMULET OCCLUDER USING SAME DELIVERY SYSTEM WITH ALL THREE DEVICES. PLEASE NOTE THAT, PER THE AMULET INSTRUCTIONS FOR USE, " IF THE DEVICE IS RETRACTED WHILE IT IS IN THE SHEATH, 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." 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. REQUESTS WERE MADE FOR ADDITIONAL PROCEDURAL DETAILS SURROUNDING THE CASE (E.G., OPERATIVE NOTES, PROCEDURE IMAGING), HOWEVER THIS INFORMATION WAS NOT SUPPLIED BY THE SITE. IT IS POSSIBLE THAT THE REPORTED OPERATIONAL DIFFICULTIES AND RE-USE OF THE DELIVERY SHEATH MAY HAVE CONTRIBUTED TO THE OBSERVED PERICARDIAL EFFUSION, HOWEVER THIS CANNOT BE CONCLUSIVELY DETERMINED. THE EXACT CAUSE OF REPORTED PERICARDIAL EFFUSION COULD NOT BE CONCLUSIVELY DETERMINED. THE REPORTED INTERVENTION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES AS A PERICARDIOCENTESIS WAS PERFORMED AND 750ML OF LIQUID WAS REMOVED FROM THE PATIENT. THERE WERE NO COMPLAINTS ASSOCIATED WITH ANY OTHER DEVICES FROM THE LOT. BASED ON THE INFORMATION RECEIVED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING, DESIGN, OR MANUFACTURING OF THE DEVICE. CODES REMOVED: HEALTH EFFECT-CLINICAL CODE: TYPE OF INVESTIGATION: 4118 TYPE OF INVESTIGATION NOT YET DETERMINED. INVESTIGATION FINDINGS: 3233 RESULTS PENDING COMPLETION OF INVESTIGATION. INVESTIGATION CONCLUSIONS: 11 CONCLUSION NOT YET AVAILABLE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER (8857697) WAS SELECTED FOR IMPLANT ON (B)(6) 2025 USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE PATIENT'S LANDING ZONE WAS MEASURED AT 21MM, 16MM, 14MM, AND 17MM AT DIFFERENT DEGREE VIEWS. TRANSSEPTAL ACCESS WAS INFERIOR MID. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVEL WAS GREATER THAN 250 SECONDS. THE PATIENT'S LEFT ATRIAL PRESSURE WAS 10MMHG. AFTER A CONTRAST SHOT THE LEFT ATRIAL APPENDAGE (LAA) APPEARED TO BE SMALLER. THE OCCLUDER WAS PARTIALLY RE-CAPTURED ONCE. AFTER DEPLOYMENT A TUG TEST WAS PERFORMED AND THE OCCLUDER APPEARED TO HAVE MOVED SLIGHTLY. THE DECISION WAS MADE TO REMOVE THE OCCLUDER AND UP-SIZE TO A NEW 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER (9213169). IT WAS NOTED THAT THE OCCLUDER WAS UNABLE TO BE SEATED COAXIALLY. THE OCCLUDER WAS PARTIALLY RE-CAPTURED TWICE. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER (8979897). THE OCCLUDER WAS UNABLE TO BE SEATING COAXIALLY DESPITE BEING DEPLOYED IN THE SAME LOCATION AS THE FIRST OCCLUDER. THE PATIENT THEN PRESENTED WITH A SMALL, CIRCUMFERENTIAL PERICARDIAL EFFUSION IN THE LEFT ATRIAL APPENDAGE (LAA). THE DECISION WAS MADE TO REMOVE THE OCCLUDER AND REPLACE IT WITH A NEW NON-ABBOTT DEVICE. WHILE PREPARING THE NEW DEVICE, IT WAS NOTED THAT THE PERICARDIAL EFFUSION WAS BECOMING LARGER. A PERICARDIOCENTESIS WAS PERFORMED AND 750ML OF LIQUID WAS REMOVED FROM THE PATIENT. THE PATIENT STATUS WAS STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER (8857697) WAS SELECTED FOR IMPLANT ON (B)(6) 2025 USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE PATIENT'S LANDING ZONE WAS MEASURED AT 21MM, 16MM, 14MM, AND 17MM AT DIFFERENT DEGREE VIEWS. TRANSSEPTAL ACCESS WAS INFERIOR MID. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVEL WAS GREATER THAN 250 SECONDS. THE PATIENT'S LEFT ATRIAL PRESSURE WAS 10MMHG. AFTER A CONTRAST SHOT THE LEFT ATRIAL APPENDAGE (LAA) APPEARED TO BE SMALLER. THE OCCLUDER WAS PARTIALLY RE-CAPTURED ONCE. AFTER DEPLOYMENT A TUG TEST WAS PERFORMED AND THE OCCLUDER APPEARED TO HAVE MOVED SLIGHTLY. THE DECISION WAS MADE TO REMOVE THE OCCLUDER AND UP-SIZE TO A NEW 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER (9213169). IT WAS NOTED THAT THE OCCLUDER WAS UNABLE TO BE SEATED COAXIALLY. THE OCCLUDER WAS PARTIALLY RE-CAPTURED TWICE. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER (8979897). THE OCCLUDER WAS UNABLE TO BE SEATING COAXIALLY DESPITE BEING DEPLOYED IN THE SAME LOCATION AS THE FIRST OCCLUDER. THE PATIENT THEN PRESENTED WITH A SMALL, CIRCUMFERENTIAL PERICARDIAL EFFUSION IN THE LEFT ATRIAL APPENDAGE (LAA). THE DECISION WAS MADE TO REMOVE THE OCCLUDER AND REPLACE IT WITH A NEW NON-ABBOTT DEVICE. WHILE PREPARING THE NEW DEVICE, IT WAS NOTED THAT THE PERICARDIAL EFFUSION WAS BECOMING LARGER. A PERICARDIOCENTESIS WAS PERFORMED AND 750ML OF LIQUID WAS REMOVED FROM THE PATIENT. THE PATIENT STATUS WAS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623941 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 9-ACP2-007-022 8979897 00811806013480

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention