BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER AMULET

    MDR report key: 22437590 · Received July 8, 2025

    Report

    Report Number
    2135147-2025-03722
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 13, 2025
    Report Date
    July 25, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    PMA / PMN Number
    P200049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REMAINS IMPLANTED IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: PREPROCEDURAL 3D TRANSESOPHAGEAL ECHOCARDIOGRAPHY FOR THE PREDICTION OF DEVICE DEFORMATION MORPHOLOGY AND PERI-DEVICE LEAKS AFTER TRANSCATHETER LEFT ATRIAL APPENDAGE OCCLUSION WITH THE AMPLATZERTM DEVICE.

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF PREPROCEDURAL 3D TRANSESOPHAGEAL ECHOCARDIOGRAPHY FOR THE PREDICTION OF DEVICE DEFORMATION MORPHOLOGY AND PERI-DEVICE LEAKS AFTER TRANSCATHETER LEFT ATRIAL APPENDAGE OCCLUSION WITH THE AMPLATZERTM DEVICE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING ATRIAL FIBRILLATION (PAROXYSMAL, PERSISTENT, PERMANENT), ARTERIAL HYPERTENSION, CHRONIC KIDNEY DISEASE, CONGESTIVE HEART FAILURE, PRIOR STROKE, PRIOR BLEEDING, INTRACRANIAL BLEEDING, GASTROINTESTINAL BLEEDING. SOME OF THE COMPLICATIONS REPORTED WERE PERICARDIAL EFFUSION, THROMBUS; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: PREPROCEDURAL 3D TRANSESOPHAGEAL ECHOCARDIOGRAPHY FOR THE PREDICTION OF DEVICE DEFORMATION MORPHOLOGY AND PERI-DEVICE LEAKS AFTER TRANSCATHETER LEFT ATRIAL APPENDAGE OCCLUSION WITH THE AMPLATZERTM DEVICE.

    Description of Event or Problem · 0

    THE ARTICLE, "PREPROCEDURAL 3D TRANSESOPHAGEAL ECHOCARDIOGRAPHY FOR THE PREDICTION OF DEVICE DEFORMATION MORPHOLOGY AND PERI-DEVICE LEAKS AFTER TRANSCATHETER LEFT ATRIAL APPENDAGE OCCLUSION WITH THE AMPLATZERTM DEVICE", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY TO COMPARE 2D TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND 3D TEE MEASUREMENTS WITH CONVENTIONAL CARDIAC ANGIOGRAPHY (CCA) AND FLUOROSCOPY IN LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) WITH THE AMPLATZER DEVICE AND THEIR ABILITY TO ASSESS THE ECCENTRICITY OF THE LAA OSTIUM AS WELL AS THEIR IMPACT ON UNFAVORABLE RESULTS. DEVICES INCLUDED IN THE STUDY WERE AMPLATZER AMULET AND AMPLATZER CARDIAC PLUG. THE ARTICLE CONCLUDED THAT UNDERSIZING AS WELL AS OVERSIZING OF THE LAA OCCLUDER, AS CHARACTERIZED BY DEFORMATION TYPE BY FLUOROSCOPY, WAS ASSOCIATED WITH POSTPROCEDURAL PERI-DEVICE LEAKS (PDLS). THE ECCENTRICITY OF THE LAA LANDING ZONE BY 3D TEE MAY INDICATE INADEQUATE SIZE SELECTION OF THE AMPLATZER DEVICE LEADING TO OVERSIZING IN PATIENTS WITH A MORE ECCENTRIC LAA. [THE PRIMARY AND CORRESPONDING AUTHOR WAS ANNEMARIE KIRSCHFINK, DEPARTMENT OF CARDIOLOGY, ANGIOLOGY AND INTENSIVE CARE, UNIVERSITY HOSPITAL, RWTH AACHEN UNIVERSITY, PAUWELSSTRASSE 30, 52074 AACHEN, GERMANY, WITH CORRESPONDING EMAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS NOT REPORTED. A TOTAL OF 47 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH ALL RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 76 YEARS AND THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED ATRIAL FIBRILLATION (PAROXYSMAL, PERSISTENT, PERMANENT), ARTERIAL HYPERTENSION, CHRONIC KIDNEY DISEASE, CONGESTIVE HEART FAILURE, PRIOR STROKE, PRIOR BLEEDING, INTRACRANIAL BLEEDING, GASTROINTESTINAL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966191 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL UNK AMPLATZER AMULET

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown