BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER DUCT OCCLUDER II

    MDR report key: 23890013 · Received December 24, 2025

    Report

    Report Number
    2135147-2025-07711
    Event Type
    Malfunction
    Date Received
    December 24, 2025
    Date of Event
    June 1, 2002
    Report Date
    February 18, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MAE
    PMA / PMN Number
    P020024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF AMPLATZER DUCT OCCLUDER II WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING PERIMEMBRANEOUS VENTRICULAR SEPTAL DEFECT. COMPLICATIONS REPORTED INCLUDED DEVICE EMBOLIZATION, SURGICAL INTERVENTION (PACEMAKER, EXPLANT), UNEXPECTED MEDICAL INTERVENTION (SNARE), HOSPITALIZATION, HEART BLOCK, AORTIC REGURGITATION, TRICUSPID REGURGITATION; 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. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. LITERATURE ATTACHMENT: AORTIC REGURGITATION FOLLOWING TRANSCATHETER CLOSURE OF PERIMEMBRANOUS VENTRICULAR SEPTAL DEFECT IN CHILDREN: RISK FACTORS AND LONG-TERM OUTCOMES. 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

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. LITERATURE ATTACHMENT: AORTIC REGURGITATION FOLLOWING TRANSCATHETER CLOSURE OF PERIMEMBRANOUS VENTRICULAR SEPTAL DEFECT IN CHILDREN: RISK FACTORS AND LONG-TERM OUTCOMES. 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, "AORTIC REGURGITATION FOLLOWING TRANSCATHETER CLOSURE OF PERIMEMBRANOUS VENTRICULAR SEPTAL DEFECT IN CHILDREN: RISK FACTORS AND LONG-TERM OUTCOMES", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY TO IDENTIFY THE RISK FACTORS FOR AORTIC REGURGITATION (AR) AND ASSESS ITS LONG-TERM OUTCOMES IN CHILDREN UNDERGOING TRANSCATHETER PERIMEMBRANOUS VENTRICULAR SEPTAL DEFECTS (PMVSD) CLOSURE. DEVICES INCLUDED IN THE STUDY WERE SHANGHAI SHAPE MEMORY ALLOY OCCLUDERS, LIFETECH SCIENTIFIC OCCLUDERS, STARWAY MEDICAL OCCLUDERS, AND AMPLATZER DUCT OCCLUDER II. THE ARTICLE CONCLUDED THAT MOST AR CASES AFTER PMVSD CLOSURE ARE MILD OR TRIVIAL WITH FAVORABLE LONG-TERM OUTCOMES. MINIMIZING REPEATED TRACK CREATIONS AND AVOIDING OPENING THE LEFT DISK ABOVE THE AORTIC VALVE MAY HELP REDUCE AR RISK, WHEREAS A SMALLER SUBAORTIC RIM MAY INCREASE ITS LIKELIHOOD. [THE PRIMARY AND CORRESPONDING AUTHOR WAS DIANDONG JIANG, DEPARTMENT OF NEONATOLOGY, SHANDONG PROVINCIAL HOSPITAL AFFILIATED TO SHANDONG FIRST MEDICAL UNIVERSITY, JINAN 250021, SHANDONG, CHINA, WITH CORRESPONDING EMAIL: [email protected]] THE TIME FRAME OF THE STUDY WAS FROM JUNE 2002 TO AUGUST 2023. A TOTAL OF 1427 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 201 (14.1%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 4.43 YEARS, THE AVERAGE WEIGHT WAS 18.52KG, AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED PERIMEMBRANEOUS VENTRICULAR SEPTAL DEFECT.

    Description of Event or Problem · 0

    THE ARTICLE, "AORTIC REGURGITATION FOLLOWING TRANSCATHETER CLOSURE OF PERIMEMBRANOUS VENTRICULAR SEPTAL DEFECT IN CHILDREN: RISK FACTORS AND LONG-TERM OUTCOMES", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY TO IDENTIFY THE RISK FACTORS FOR AORTIC REGURGITATION (AR) AND ASSESS ITS LONG-TERM OUTCOMES IN CHILDREN UNDERGOING TRANSCATHETER PERIMEMBRANOUS VENTRICULAR SEPTAL DEFECTS (PMVSD) CLOSURE. DEVICES INCLUDED IN THE STUDY WERE SHANGHAI SHAPE MEMORY ALLOY OCCLUDERS, LIFETECH SCIENTIFIC OCCLUDERS, STARWAY MEDICAL OCCLUDERS, AND AMPLATZER DUCT OCCLUDER II. THE ARTICLE CONCLUDED THAT MOST AR CASES AFTER PMVSD CLOSURE ARE MILD OR TRIVIAL WITH FAVORABLE LONG-TERM OUTCOMES. MINIMIZING REPEATED TRACK CREATIONS AND AVOIDING OPENING THE LEFT DISK ABOVE THE AORTIC VALVE MAY HELP REDUCE AR RISK, WHEREAS A SMALLER SUBAORTIC RIM MAY INCREASE ITS LIKELIHOOD. [THE PRIMARY AND CORRESPONDING AUTHOR WAS DIANDONG JIANG, DEPARTMENT OF NEONATOLOGY, SHANDONG PROVINCIAL HOSPITAL AFFILIATED TO SHANDONG FIRST MEDICAL UNIVERSITY, JINAN 250021, SHANDONG, CHINA, WITH CORRESPONDING EMAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS FROM JUNE 2002 TO AUGUST 2023. A TOTAL OF 1427 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 201 (14.1%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 4.43 YEARS, THE AVERAGE WEIGHT WAS 18.52KG, AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED PERIMEMBRANEOUS VENTRICULAR SEPTAL DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2477077 AMPLATZER DUCT OCCLUDER II OCCLUDER, PATENT DUCTUS, ARTERIOSUS MAE ABBOTT MEDICAL UNK AMPLATZER DUCT OCCLUDER II

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown