BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 20278663 · Received September 23, 2024

    Report

    Report Number
    2135147-2024-04662
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    August 29, 2024
    Report Date
    November 12, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013459
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 THROMBUS 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. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE REPORTED UNEXPECTED MEDICAL INTERVENTION WAS RELATED TO ADMINISTRATION OF MEDICATION (ANTICOAGULANT). THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Description of Event or Problem · 0

    (B)(6) - CATALYST IDE, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 16MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT WITH A 12F AMPLATZER AMULET DELIVERY SHEATH. AT THE START OF PROCEDURE, THE PATIENT'S ATRIAL RHYTHM WAS AT ATRIAL FLUTTER. THE PATIENT'S LEFT ATRIAL APPENDAGE (LAA) DIMENSIONS WERE AS FOLLOWS: LAA DEPTH = 16MM, LAA ORIFICE = 13MM, LANDING ZONE = 11-13MM, AND LA PRESSURE = 9MMHG). THE PATIENT'S MOST RECENT INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.0 ON (B)(6) 2024. DURING PROCEDURE, HEPARIN WAS ADMINISTERED AND THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS RANGED 212-289 SECONDS. DURING PROCEDURE, THERE WERE 3 PARTIAL RECAPTURES BEFORE THE 16MM AMPLATZER AMULET WAS COMPLETELY RECAPTURED PRIOR TO RELEASE FROM THE DELIVERY CABLE AND REMOVED FROM THE PATIENT. IT WAS THEN DECIDED TO ATTEMPT AN IMPLANT WITH AN 18MM AMPLATZER AMULET BUT IT WAS ALSO UNSUCCESSFUL DUE "SPONTANEOUS DISLOCATION AND OVER-COMPRESSION BECAUSE OF SIZED MIS-MATCH" AND WAS SUBSEQUENTLY RECAPTURED PRIOR TO RELEASE FROM THE DELIVERY CABLE AND REPLACED. A DECISION WAS MADE TO REUSE THE FIRST 16MM AMPLATZER AMULET BUT DURING DEVICE PREPARATION, IT WAS NOTED THAT THE LOADER WAS BROKEN AND THE DEVICE WAS NOT ASPIRATING PROPERLY. IT WAS OBSERVED THAT THERE WAS RESISTANCE, AIR WAS LOST FROM THE CATHETER, AND THERE WAS AN AIR LEAK IN THE LOADER SHEATH. THE 16MM AMPLATZER AMULET WAS THEN REPLACED WITH A SECOND 16MM AMPLATZER AMULET. THERE WERE 2 PARTIAL RECAPTURES BEFORE THE DEVICE WAS SUCCESSFULLY IMPLANTED. IT WAS REPORTED THE SAME 12F AMPLATZER AMULET DELIVERY SHEATH WAS REUSED FOR ALL THREE AMULET DEVICES AND REMAINED IN THE PATIENT FOR 54MIN DURING THE PROCEDURE. IT WAS THEN REPORTED ON 29 AUGUST 2024, A FOLLOW-UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) NOTED A LARGE THROMBUS ON THE DEVICE. THE THROMBUS WAS NOTED "PEDUNCULATED" AND "ROUND" IN SHAPE, NOT FIBER-LIKE IN SHAPE, AND LOCATED ON THE SURFACE OF AMULET DISC, MEASURING 10X13MM. THE PATIENT WAS STARTED ON ANTICOAGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488632 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 8798976 00811806013459

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention AMPLATZER AMULET DS, DS-TV45X45-12F-080