BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 20102129 · Received August 29, 2024

    Report

    Report Number
    2135147-2024-04294
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    August 7, 2024
    Report Date
    October 25, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013497
    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

    IT WAS REPORTED THAT DURING IMPLANT IT WAS SUSPECTED THAT THERE WAS A POTENTIAL THROMBUS IN BETWEEN THE DISC AND LOBE NEAR MITRAL JUNCTION WHILE IN THE LEFT ATRIAL APPENDAGE. THE DISC COMPONENT WAS UN-SHEATHED TO CAPTURE THE CLOT, THERE WAS NO MOVEMENT OF THE CLOT NOTED. THE DECISION WAS MADE TO RELEASE THE DEVICE FROM THE DELIVERY CABLE. INFORMATION FROM FIELD INDICATED THAT 20 MM AMULET DEVICE WAS REMOVED FROM THE PATIENT DUE TO DEVICE BEING SMALL AND REPLACED WITH 25 MM AMULET USING SAME SHEATH. PLEASE NOTE THAT PER THE INSTRUCTIONS FOR USE, (B)(6), "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." AND "EVALUATE THE PATIENT USING TEE OR ICE TO RULE OUT THE PRESENCE OF INTRACARDIAC THROMBUS (INCLUDING LEFT ATRIAL APPENDAGE THROMBUS) AND PRESENCE OF PERICARDIAL EFFUSION." ONE IMAGE WAS PROVIDED AND REVIEWED AT ABBOTT, THE SINGLE IMAGE WAS NOT SUFFICIENT TO CONFIRM THE REPORTED EVENT. THERE MAY BE AN OBJECT BETWEEN THE DISC AND LOBE, BUT IT IS DIFFICULT TO CONFIRM WITH THE IMAGE PROVIDED. THE DEVICE REMAINS IMPLANTED AND WILL NOT RETURN TO ABBOTT 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. IT IS POSSIBLE THAT THE REPORTED RE-USE OF THE DELIVERY SHEATH MAY HAVE CONTRIBUTED , HOWEVER THIS CANNOT BE CONCLUSIVELY DETERMINED. THROMBUS IS A POSSIBLE OUTCOME OF THE PROCEDURE PER THE AMPLATZER AMULET INSTRUCTIONS FOR USE, ARTEN600142796 REVISION C. THERE WERE NO COMPLAINTS ASSOCIATED WITH ANY OTHER DEVICES FROM THE LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING, DESIGN, OR MANUFACTURING OF THE DEVICE.

    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 20MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE LEFT ATRIAL APPENDAGE (LAA) WAS MEASURED WITH THE MAX LANDING ZONE AS 24MM, THE ORIFICE AS 18MM, AND THE DEPTH AS 16MM. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS WERE BETWEEN 250-370 SEC. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS USED DURING THE PROCEDURE. DURING IMPLANT IT WAS DETERMINED THROUGH 2D ECHOCARDIOGRAM THAT THE DEVICE WAS TOO SMALL FOR THE LAA. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 25MM AMPLATZER LEFT ATRIAL APPENDAGE OCCLUDER USING THE SAME DELIVERY SHEATH. DURING IMPLANT IT WAS SUSPECTED THAT THERE WAS A POTENTIAL THROMBUS IN BETWEEN THE DISC AND LOBE NEAR MITRAL JUNCTION WHILE IN THE LEFT ATRIAL APPENDAGE. THE DISC COMPONENT WAS UN-SHEATHED TO CAPTURE THE CLOT. THERE WAS NO MOVEMENT OF THE CLOT NOTED. THE DECISION WAS MADE TO RELEASE THE DEVICE FROM THE DELIVERY CABLE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT STATUS WAS STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS WERE BETWEEN 250-370 SEC. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS USED DURING THE PROCEDURE. DURING THE PROCEDURE IT WAS NOTED THAT THERE WAS A POTENTIAL THROMBUS IN BETWEEN THE DISC AND LOBE NEAR MITRAL JUNCTION WHILE IN THE LEFT ATRIAL APPENDAGE. THE DISC COMPONENT WAS UN-SHEATHED TO CAPTURE THE CLOT. THERE WAS NO MOVEMENT OF THE CLOT NOTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803472 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 9165844 00811806013497

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other