BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER MEMBRANOUS VSD OCCLUDER

    MDR report key: 21773325 · Received April 4, 2025

    Report

    Report Number
    2135147-2025-01721
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    June 1, 2002
    Report Date
    April 4, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P040040
    Adverse Event
    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 MEMBRANOUS VSD OCCLUDER WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING VENTRICULAR SEPTAL DEFECT, MEMBRANOUS ANEURYSMS, AND ANEURYSMAL TISSUE INVOLVING THE TRICUSPID VALVE. COMPLICATIONS REPORTED INCLUDED SURGICAL INTERVENTION (EXPLANT), TRICUSPID REGURGITATION. 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. B3: DATE OF EVENT IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: ARTICLE TITLE: RISK FACTORS AND LONG-TERM OUTCOMES OF TRICUSPID REGURGITATION AFTER TRANSCATHETER CLOSURE OF PEDIATRIC PERIMEMBRANOUS VENTRICULAR SEPTAL DEFECTS."

    Description of Event or Problem · 0

    THE ARTICLE, "RISK FACTORS AND LONG-TERM OUTCOMES OF TRICUSPID REGURGITATION AFTER TRANSCATHETER CLOSURE OF PEDIATRIC PERIMEMBRANOUS VENTRICULAR SEPTAL DEFECTS", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY TO INVESTIGATE THE RISK FACTORS AND LONG-TERM OUTCOMES OF NEW-ONSET OR PROGRESSED TRICUSPID REGURGITATION (TR) IN CHILDREN FOLLOWING TRANSCATHETER PERIMEMBRANOUS VENTRICULAR SEPTAL DEFECT (PMVSD) CLOSURE. DEVICES INCLUDED IN THE STUDY WERE AMPLATZER VSD OCCLUDER, MODIFIED SHANGHAI SHAPE MEMORY ALLOY, LIFETECH SCIENTIFIC, STARWAY MEDICAL, AND AMPLATZER DUCT OCCLUDER II. THE ARTICLE CONCLUDED THAT TR FOLLOWING PERIMEMBRANOUS VENTRICULAR SEPTAL DEFECT CLOSURE IS COMMON BUT TYPICALLY MILD AND OFTEN RESOLVES OVER TIME. A LARGER RIGHT DISC DIAMETER RELATIVE TO BODY WEIGHT SIGNIFICANTLY INCREASES THE RISK OF TR, EMPHASIZING THE IMPORTANCE OF CAREFUL DEVICE SIZING, PARTICULARLY IN LIGHTER PATIENTS. LONG-TERM FOLLOW-UP IS CRUCIAL TO DETECT POTENTIAL LATE PROGRESSION OF TR. [THE PRIMARY AND CORRESPONDING AUTHOR WAS BO HAN, DEPARTMENT OF PEDIATRIC CARDIOLOGY, SHANDONG PROVINCIAL HOSPITAL AFFILIATED TO SHANDONG FIRST MEDICAL UNIVERSITY,NO. 324 JINGWU ROAD, JINAN 250021, CHINA, WITH CORRESPONDING EMAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS FROM JUNE 2002 TO DECEMBER 2022. A TOTAL OF 1343 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH AT LEAST 15.3% RECEIVED AN AMPLATZER DUCT OCCLUDER II AND IT WAS NOT REPORTED HOW MANY RECEIVED AN AMPLATZER VSD OCCLUDER (AMPLATZER VSD OCCLUDER IS CATEGORIZED IN ECCENTRIC GROUP, 12.6% OF POPULATION, ALONG WITH NON-ABBOTT DEVICES). THE AVERAGE AGE WAS 4.41 YEARS AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED VENTRICULAR SEPTAL DEFECT, MEMBRANOUS ANEURYSMS, AND ANEURYSMAL TISSUE INVOLVING THE TRICUSPID VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262703 AMPLATZER MEMBRANOUS VSD OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL UNKAMPLATZERMEMBRANOUSOCCLUDER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention