BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 20462974 · Received October 16, 2024

    Report

    Report Number
    2135147-2024-05100
    Event Type
    Injury
    Date Received
    October 16, 2024
    Date of Event
    September 23, 2024
    Report Date
    November 27, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013503
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 FOR PATIENT EFFECTS OF 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 DEFINED MANUFACTURING SPECIFICATIONS. THE PROVIDED INFORMATION WAS REVIEWED BY MEDICAL AFFAIRS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION COULD NOT BE CONCLUSIVELY DETERMINED. THE REPORTED SURGICAL INTERVENTION WAS THE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. 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 A 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE FIRST TRANSSEPTAL PUNCTURE WAS THROUGH THE PATENT FORAMEN OVALE (PFO). THE SECOND TRANSSEPTAL PUNCTURE WAS LOW MID. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS WERE 220, 269, AND 232 SEC. THE PATIENT'S LEFT ATRIAL PRESSURE WAS 13MMHG. DURING IMPLANT THE DEVICE WAS PARTIALLY RE-CAPTURED TWICE. POST THE FIRST DEPLOYMENT ATTEMPT THE PATIENT PRESENTED WITH AN ACUTE CIRCUMFERENTIAL PERICARDIAL EFFUSION SURROUNDING THE LEFT ATRIUM. THE LARGEST DIMENSION OF THE EFFUSION WAS 2CM. AN ATTEMPT WAS MADE TO DEPLOY THE DEVICE. THE DECISION WAS MADE TO REMOVE BOTH THE OCCLUDER AND DELIVERY SHEATH FROM THE PATIENT. A NEW 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER AND 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WERE USED TO MITIGATE THE LEAK. A PERICARDIAL WINDOW WAS PERFORMED. THE PATIENT STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322750 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 10327365 00811806013503

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention AMPLATZER TORQVUE 45X45 DS, 9-TV45X45-14F-080.