BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 17847652 · Received September 29, 2023

    Report

    Report Number
    2135147-2023-04253
    Event Type
    Injury
    Date Received
    September 29, 2023
    Date of Event
    September 7, 2023
    Report Date
    November 21, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013497
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT RETURNING FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    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 PERICARDIAL EFFUSION WAS REPORTED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. INFORMATION FROM THE FIELD INDICATED THAT THE PERICARDIAL EFFUSION WAS NOT DUE TO THE AMULET DEVICE BUT WAS DUE TO MANIPULATIONS OF THE SHEATH. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS IMPLANTED WITH A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE PATIENTS LEFT ATRIAL APPENDAGE (LAA) MEASUREMENTS WERE AS FOLLOWED: LAA ORIFICE - 30MM (0' DEG), 30MM (45 DEG), 29MM (90 DEG), 30MM (135 DEG); LANDING ZONE - 25MM (0' DEG), 17-25MM (45 DEG), 16MM (90 DEG), 21MM (135 DEG); AND LAA DEPTH- 38MM (0' DEG), 32MM (45 DEG), 26MM (90 DEG), 22MM (135 DEG). THERE WAS NO BASELINE EFFUSION NOTED. DURING PROCEDURE, THE PATIENT'S ACTIVATED CLOTTING TIME LEVEL WAS 298 SECONDS AND HEPARIN WAS ADMINISTERED. IT WAS REPORTED 1-2 HOURS POST-PROCEDURE, THE PATIENT DEVELOPED PERICARDIAL EFFUSION. A DECISION WAS MADE TO PERFORM A PERICARDIOCENTESIS. THE PATIENT STATUS WAS STABLE AND DISCHARGED ON (B)(6) 2023.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS IMPLANTED WITH A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE PATIENTS LEFT ATRIAL APPENDAGE (LAA) MEASUREMENTS WERE AS FOLLOWED: LAA ORIFICE - 30MM (0' DEG), 30MM (45 DEG), 29MM (90 DEG), 30MM (135 DEG); LANDING ZONE - 25MM (0' DEG), 17-25MM (45 DEG), 16MM (90 DEG), 21MM (135 DEG); AND LAA DEPTH- 38MM (0' DEG), 32MM (45 DEG), 26MM (90 DEG), 22MM (135 DEG). THERE WAS NO BASELINE EFFUSION NOTED. DURING PROCEDURE, THE PATIENT'S ACTIVATED CLOTTING TIME LEVEL WAS 298 SECONDS AND HEPARIN WAS ADMINISTERED. IT WAS REPORTED THE PATIENT HAD A PROMINENT PULMONARY VEIN (PV) RIDGE THAT MADE SHEATH MANIPULATION DIFFICULT TO MANEUVER INTO THE LAA. IT WAS REPORTED A WIRE AND PIGTAIL CATHETER WERE INSERTED TO ASSIST THE DELIVERY SHEATH BACK INTO THE LAA. THERE WAS NO REPORT OF THE DEVICE EVER BEING COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM. IT WAS REPORTED 1-2 HOURS POST-PROCEDURE, THE PATIENT DEVELOPED PERICARDIAL EFFUSION THAT LED TO CARDIAC TAMPONADE. A DECISION WAS MADE TO PERFORM A PERICARDIOCENTESIS. THE PATIENT STATUS WAS STABLE AND DISCHARGED ON (B)(6) 2023.

    Description of Event or Problem · 0

    CLINICAL INFORMATION: (B)(6) - ADVANCE LAA, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS IMPLANTED WITH A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE PATIENTS LEFT ATRIAL APPENDAGE (LAA) MEASUREMENTS WERE AS FOLLOWED: LAA ORIFICE - 30MM (0' DEG), 30MM (45 DEG), 29MM (90 DEG), 30MM (135 DEG); LANDING ZONE - 25MM (0' DEG), 17-25MM (45 DEG), 16MM (90 DEG), 21MM (135 DEG); AND LAA DEPTH- 38MM (0' DEG), 32MM (45 DEG), 26MM (90 DEG), 22MM (135 DEG). THERE WAS NO BASELINE EFFUSION NOTED. DURING PROCEDURE, THE PATIENT'S ACTIVATED CLOTTING TIME LEVEL WAS 298 SECONDS AND HEPARIN WAS ADMINISTERED. IT WAS REPORTED THE PATIENT HAD A PROMINENT PULMONARY VEIN (PV) RIDGE THAT MADE SHEATH MANIPULATION DIFFICULT TO MANEUVER INTO THE LAA. IT WAS REPORTED A WIRE AND PIGTAIL CATHETER WERE INSERTED TO ASSIST THE DELIVERY SHEATH BACK INTO THE LAA. THERE WAS NO REPORT OF THE DEVICE EVER BEING COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM. IT WAS REPORTED 1-2 HOURS POST-PROCEDURE, THE PATIENT DEVELOPED PERICARDIAL EFFUSION THAT LED TO CARDIAC TAMPONADE. A DECISION WAS MADE TO PERFORM A PERICARDIOCENTESIS. THE PATIENT STATUS WAS STABLE AND DISCHARGED ON 11 SEPTEMBER 2023. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344496 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 8764680 00811806013497

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention