BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 24569647 · Received March 11, 2026

    Report

    Report Number
    2135147-2026-01533
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    February 18, 2026
    Report Date
    March 20, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN A RESEARCH ARTICLE, "FOUR CASES OF SUCCESSFUL RETREATMENT FOLLOWING INITIAL FAILURE OF PERCUTANEOUS ATRIAL SEPTAL DEFECT CLOSURE," AN ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM WAS REPORTED WITH HEART BLOCK. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED HEART BLOCK COULD NOT BE CONCLUSIVELY DETERMINED. UNEXPECTED MEDICAL INTERVENTIONS WERE A RESULT OF CASE SPECIFIC CIRCUMSTANCES, AS THE DEVICE WAS SNARED AND SEPTAL DEFECT WAS CLOSED AT A LATER DATE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING, DESIGN, OR MANUFACTURING OF THE DEVICE. B3: EVENT DATE WAS ESTIMATED D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN IF THE DEVICE IS RETURNING FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. B3: EVENT DATE WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THE ARTICLE, "FOUR CASES OF SUCCESSFUL RETREATMENT FOLLOWING INITIAL FAILURE OF PERCUTANEOUS ATRIAL SEPTAL DEFECT CLOSURE", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 7-YEAR-OLD FEMALE PATIENT WHO PRESENTED WITH AN ATRIAL SEPTAL DEFECT (ASD). THE DEFECT MEASURED 18.3MM X 12.2MM. AN 18MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON AN UNKNOWN DATE. THE DEVICE WAS DEPLOYED. UPON DEVICE IMPLANT THE PATIENT WENT INTO COMPLETE HEART BLOCK. THE DEVICE WAS RETRIEVED AND REMOVED FROM THE PATIENT. APPROXIMATELY FOUR YEARS LATER A 44MM GORE CARDIOFORM WAS IMPLANTED TO CLOSE THE ASD. [THE PRIMARY AND CORRESPONDING AUTHOR WAS AKARI YOSHIDA, KISHINOURA 1-8-1 KITAKYUSHU CITY HACHIMANISHI WARD, FUKUOKA 8060034 JAPAN.]

    Description of Event or Problem · 0

    THE ARTICLE, "FOUR CASES OF SUCCESSFUL RETREATMENT FOLLOWING INITIAL FAILURE OF PERCUTANEOUS ATRIAL SEPTAL DEFECT CLOSURE", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 7-YEAR-OLD FEMALE PATIENT WHO PRESENTED WITH AN ATRIAL SEPTAL DEFECT (ASD). THE DEFECT MEASURED 18.3MM X 12.2MM. AN 18MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON AN UNKNOWN DATE. THE DEVICE WAS DEPLOYED. UPON DEVICE IMPLANT THE PATIENT WENT INTO COMPLETE HEART BLOCK. THE DEVICE WAS RETRIEVED AND REMOVED FROM THE PATIENT. APPROXIMATELY FOUR YEARS LATER A 44MM GORE CARDIOFORM WAS IMPLANTED TO CLOSE THE ASD. [THE PRIMARY AND CORRESPONDING AUTHOR WAS AKARI YOSHIDA, KISHINOURA 1-8-1 KITAKYUSHU CITY HACHIMANISHI WARD, FUKUOKA 8060034 JAPAN.]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628764 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL 9-ASD-018

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Female Required Intervention| H