BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER AMULET

    MDR report key: 21360548 · Received February 11, 2025

    Report

    Report Number
    2135147-2025-00684
    Event Type
    Death
    Date Received
    February 11, 2025
    Date of Event
    January 19, 2025
    Report Date
    March 14, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013503
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    AN EVENT FOR PATIENT EFFECTS OF PULMONARY EDEMA, HEMOPTYSIS, AND DEATH 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 DEFINED MANUFACTURING SPECIFICATIONS. THE PROVIDED IMAGING WAS REVIEWED BY MEDICAL AFFAIRS AND ABBOTT CLINICAL ENGINEERING MANAGER. BASED ON THE INFORMATION RECEIVED, A CAUSE FOR THE REPORTED PULMONARY EDEMA, HEMOPTYSIS, AND DEATH COULD NOT BE CONCLUSIVELY DETERMINED. 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) 2025, A 31MM AMPLATZER AMULET WAS SELECTED FOR IMPLANT USING A 14F AMPLATZER TORQVUE DELIVERY SYSTEM (LOT: 9115457). COMPUTED TOMOGRAPHY (CT) AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS USED TO DETERMINE THE SIZE. DURING PROCEDURE, AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS TO IMPLANT THE AMULET DUE TO BEING TOO LARGE WITH SUBOPTIMAL POSITION, IT WAS REMOVED. THE 31MM AMULET WAS EXCHANGED FOR A NEW 28MM AMPLATZER AMULET (LOT: 9051988). THE SHEATH WAS NOT EXCHANGED PER PHYSICIAN PREFERENCE AND ASPIRATED. THE 28MM AMULET WAS UNSHEATHED TO BALL, BUT WAS NOT DEPLOYED AS A SMALL THROMBUS WAS OBSERVED AT THE TIP OF THE SHEATH. NO DEPLOYMENTS WERE ATTEMPTED WITH THIS DEVICE AND IT WAS WITHDRAWN FROM THE SHEATH. THE SHEATH WAS AGAIN ASPIRATED, BUT AGAIN NOT EXCHANGED DUE TO PHYSICIAN PREFERENCE. ANOTHER NEW 28MM AMPLATZER AMULET (LOT: 8875300) WAS SELECTED AND ATTEMPTED TO BE IMPLANTED, HOWEVER THIS WAS UNSUCCESSFUL DUE TO SUBOPTIMAL POSITION AND WAS REMOVED FROM THE PATIENT. A NEW TRANSSEPTAL PUNCTURE (TSP) WAS ELECTED TO OPTIMIZE THE APPROACH; THE NEW TSP PROVIDED A MORE FAVORABLE APPROACH. A THIRD NEW 28MM AMPLATZER AMULET (LOT: 8898897) WAS SELECTED FOR IMPLANT USING A NEW 14F AMPLATZER TORQVUE DELIVERY SYSTEM (LOT: 10256632). THE THIRD 28MM AMULET WAS PLACED AND PASSED TENSION TEST. TEE ASSESSMENT WAS COMPLETED. SECOND TENSION WAS PERFORMED TO ENSURE DEVICE STABILITY AND CLOSE CRITERIA WAS ACHIEVED. THE DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT'S CONDITION POST-IMPLANT WAS STABLE AND WELL. ON (B)(6) 2025, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH PULMONARY EDEMA AND COUGHING WITH BLOODY SPUTUM. THE PHYSICIAN SUSPECTED DEVICE EMBOLIZATION. ON (B)(6) 2025, THE PATIENT PASSED AWAY DUE TO UNKNOWN CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845821 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 8898897 00811806013503

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Death