BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER CARDIAC PLUG

    MDR report key: 9787742 · Received March 4, 2020

    Report

    Report Number
    2135147-2020-00050
    Event Type
    Injury
    Date Received
    March 4, 2020
    Report Date
    March 4, 2020
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED IN A RESEARCH ARTICLE, A ONE PATIENT HAD AN AMPLATZER VASCULAR PLUG III IMPLANTED OFF LABEL TO CLOSE A LEAK AFTER INCOMPLETE CLOSURE OF THE LAA WITH A CARDIAC PLUG. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PLEASE NOTE, PER THE INSTRUCTIONS FOR USE FOR THE AMPLATZER VASCULAR PLUG III, 600229-004 REVISION A, "THE SAFETY AND EFFECTIVENESS OF THIS DEVICE FOR CARDIAC USES (E.G. PATIENT DUCTUS ARTERIOSUS, PARAVALVULAR LEAK CLOSURES) AND NEUROLOGICAL USES HAVE NOT BEEN ESTABLISHED."

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AMPLATZER CARDIAC PLUG THAT MAY BE RELATED TO REDO PROCEDURE REQUIRING IMPLANT OF A 14MM AMPLATZER VASCULAR PLUG III. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED "INTERVENTIONAL TREATMENT OF INCOMPLETE SEAL AFTER TRANSCATHETER OR SURGICAL LEFT ATRIAL APPENDAGE CLOSURE."

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AMPLATZER CARDIAC PLUG THAT MAY BE RELATED TO REDO PROCEDURE REQUIRING IMPLANT OF A 14MM AMPLATZER VASCULAR PLUG III. TRANSCATHETER CLOSURE OF THE LEFT ATRIAL APPENDAGE (LAA) FOR STROKE PREVENTION HAS EMERGED AS AN ALTERNATIVE TO SYSTEMIC ANTICOAGULATION IN PATIENTS WITH ATRIAL FIBRILLATION (AFIB) AND INCREASED STROKE RISK. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED "INTERVENTIONAL TREATMENT OF INCOMPLETE SEAL AFTER TRANSCATHETER OR SURGICAL LEFT ATRIAL APPENDAGE CLOSURE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247762 AMPLATZER CARDIAC PLUG TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention