BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 19070915 · Received April 9, 2024

    Report

    Report Number
    2135147-2024-01608
    Event Type
    Injury
    Date Received
    April 9, 2024
    Date of Event
    March 15, 2024
    Report Date
    May 22, 2024
    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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 IMPROPER OR INCORRECT PROCEDURE OR METHOD AND PERICARDIAL EFFUSION WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED AND 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. THERE ARE MULTIPLE RISK FACTORS FOR PERICARDIAL EFFUSION AFTER A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE, INCLUDING ANTICOAGULATION STATUS OF THE PATIENT, MANEUVERING OF THE GUIDEWIRE OR SHEATHS WITHIN THE HEART, THE TRANS-SEPTAL PUNCTURE, OR THE STABILIZING WIRES ON THE AMULET PUNCTURING THE LAA. IT WAS REPORTED THAT THE PATIENT WAS NOTED TO HAVE A DIFFICULT CHICKEN WING-SHAPED LEFT ATRIAL APPENDAGE. HEPARIN WAS GIVEN MULTIPLE TIMES, AND THE PATIENT'S ACTIVATING CLOT TIME LEVELS WERE 250-350 SECONDS. THE TRANSSEPTAL PUNCTURE WAS INFERIOR MID. DURING THE PROCEDURE, THE DEVICE WAS PARTIALLY RE-CAPTURED THREE TIMES. THE DEVICE WAS IMPLANTED. THEN, THE PATIENT PRESENTED WITH A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. THE USER BELIEVED THE PERICARDIAL EFFUSION WAS CAUSED BY THE MULTIPLE DEVICE RECAPTURES. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE REPORTED INCIDENT APPEARS TO RELATED TO PROCEDURAL CONDITIONS (DEVICE RECAPTURED MULTIPLE TIMES). THE REPORTED IMPROPER OR INCORRECT PROCEDURE OR METHOD WAS RELATED TO USER TECHNIQUE AS THE USER PARTIALLY RECAPTURED THE DEVICE THREE TIMES. PLEASE NOTE THAT PER THE INSTRUCTION FOR USE: THE DEVICE CAN BE PARTIALLY RECAPTURED AND REDEPLOYED A MAXIMUM OF THREE TIMES. IF THE DEVICE POSITION IS STILL UNSATISFACTORY, THEN REMOVE AND REPLACE BOTH THE DEVICE AND THE SHEATH."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 14F AMULET STEERABLE DELIVERY SHEATH. THE PATIENT WAS NOTED TO HAVE A DIFFICULT CHICKEN WING-SHAPED LEFT ATRIAL APPENDAGE. HEPARIN WAS GIVEN MULTIPLE TIMES, AND THE PATIENT'S ACTIVATING CLOT TIME LEVELS WERE 250-350 SECONDS. THE TRANSSEPTAL PUNCTURE WAS INFERIOR MID. THE LEFT ATRIAL PRESSURE WAS 15MMHG. DURING THE PROCEDURE, THE DEVICE WAS PARTIALLY RE-CAPTURED THREE TIMES. THE DEVICE WAS IMPLANTED. FOUR HOURS POST-IMPLANT, THE PATIENT PRESENTED WITH A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED WITH 150ML OF FLUID DRAINED. THE USER BELIEVED THE PERICARDIAL EFFUSION WAS CAUSED BY THE MULTIPLE DEVICE RECAPTURES. THE PATIENT STATUS WAS STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 14F AMULET STEERABLE DELIVERY SHEATH. THE PATIENT WAS NOTED TO HAVE A DIFFICULT CHICKEN WING-SHAPED LEFT ATRIAL APPENDAGE. HEPARIN WAS GIVEN MULTIPLE TIMES, AND THE PATIENT'S ACTIVATING CLOT TIME LEVELS WERE 250-350 SECONDS. THE TRANSSEPTAL PUNCTURE WAS INFERIOR MID. THE LEFT ATRIAL PRESSURE WAS 15MMHG. DURING THE PROCEDURE, THE DEVICE WAS PARTIALLY RE-CAPTURED THREE TIMES. THE DEVICE WAS IMPLANTED. FOUR HOURS POST-IMPLANT, THE PATIENT PRESENTED WITH A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED WITH 150ML OF FLUID DRAINED. THE USER BELIEVED THE PERICARDIAL EFFUSION WAS CAUSED BY THE MULTIPLE DEVICE RECAPTURES. THE PATIENT STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512662 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 8816670 00811806013480

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention