BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 19351235 · Received May 20, 2024

    Report

    Report Number
    2135147-2024-02257
    Event Type
    Injury
    Date Received
    May 20, 2024
    Date of Event
    April 22, 2024
    Report Date
    July 29, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF PATIENT DEVICE INTERACTION PROBLEM ASSOCIATED WITH THROMBUS, AIR/GAS IN DEVICE, AND IMPROPER OR INCORRECT PROCEDURE OR METHOD WAS REPORTED. 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. INFORMATION FROM THE FIELD INDICATED THAT DURING PROCEDURE, THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS MEASURED 240-347 SECONDS AND THEY WERE ADMINISTERED HEPARIN. DURING PROCEDURE, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) NOTED A FLOATING, "FIBER-LIKE" STRUCTURE OBSERVED NEAR THE CENTER OF THE RETENTION DISC. SUSPECTING THROMBUS, A DECISION WAS MADE TO ADVANCE THE DELIVERY SHEATH CLOSE TO THE BLOOD CLOT AND ASPIRATE WITH A SYRINGE. IT WAS REPORTED AIR WAS FOUND INSIDE THE SHEATH WHICH AFFECTED THE "ACTION OF REVERSE BLOOD FLOW TO THE OUTSIDE OF THE BODY". NO AIR EMBOLUS WAS OBSERVED IN THE PATIENT AND NO ST ELEVATION WAS NOTED. ADDITIONALLY, AN IMAGE WAS RECEIVED FROM THE ACCOUNT AND IT SHOWED THROMBUS. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE OF THE REPORTED THROMBUS AND AIR IN DEVICE COULD NOT BE DETERMINED. THE REPORTED IMPROPER OR INCORRECT PROCEDURE OR METHOD APPEARS TO BE RELATED TO USER PERFORMED ASPIRATION TO REMOVE THROMBUS. THE REPORTED UNEXPECTED MEDICAL INTERVENTIONS WERE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. 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

    CRD 964_CATALYST IDE, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT WITH A 14F AMPLATZER TORQVUE DELIVERY SHEATH. THE PATIENT'S MOST RECENT INTERNATIONAL NORMALIZED RATIO (INR) WAS 0.97. THE PATIENT'S LAST ANTICOAGUATION DOSE WAS TAKEN ON (B)(6) 2024. THE PATIENT'S LEFT ATRIAL APPENDAGE (LAA) MEASUREMENTS WERE AS FOLLOWS: LAA ORIFICE AT WIDEST = 25.2MM; LAA DEPTH = 33.5MM; LAA LANDING ZONE = 23.0-29.4MM. DURING PROCEDURE, THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS MEASURED 240-347 SECONDS AND THEY WERE ADMINISTERED HEPARIN. DURING PROCEDURE, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) NOTED A FLOATING, "FIBER-LIKE" STRUCTURE OBSERVED NEAR THE CENTER OF THE RETENTION DISC. SUSPECTING THROMBUS, A DECISION WAS MADE TO ADVANCE THE DELIVERY SHEATH CLOSE TO THE BLOOD CLOT AND ASPIRATE WITH A SYRINGE. IT WAS REPORTED AIR WAS FOUND INSIDE THE SHEATH WHICH AFFECTED THE "ACTION OF REVERSE BLOOD FLOW TO THE OUTSIDE OF THE BODY". NO AIR EMBOLUS WAS OBSERVED IN THE PATIENT AND NO ST ELEVATION WAS NOTED. IT WAS REPORTED THE IMAGE OF THE THROMBUS HAD ALMOST DISAPPEARED DURING TEE SO WHEN THE DELIVERY CABLE WAS RELEASED FROM THE AMULET, THE TIP OF THE DELIVERY CABLE WAS CHECKED AFTER REMOVAL FROM THE PATIENT'S BODY. IT WAS FOUND THERE WAS THROMBUS ATTACHED TO THE CABLE. THE PATIENT STATUS WAS REPORTED AS RECOVERED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1605663 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 8249337

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention AMPLATZER TORQVUE 45X45 DS, 9-TV45X45-14F-080