BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER MUSCULAR VSD OCCLUDER

    MDR report key: 21396925 · Received February 18, 2025

    Report

    Report Number
    2135147-2025-00809
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 1, 2019
    Report Date
    March 7, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P040040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURE INVESTIGATION IS NOT YET COMPLETE. 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. LITERATURE ATTACHMENT: ARTICLE TITLE: TRANSCATHETER CLOSURE OF VENTRICULAR SEPTAL DEFECTS AFTER UPFRONT TRANSVENOUS ANTEGRADE CANNULATION FROM THE RIGHT VENTRICLEER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. LITERATURE ATTACHMENT: ARTICLE TITLE: TRANSCATHETER CLOSURE OF VENTRICULAR SEPTAL DEFECTS AFTER UPFRONT TRANSVENOUS ANTEGRADE CANNULATION FROM THE RIGHT VENTRICLE.

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF AMPLATZER MUSCULAR VSD OCCLUDER WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING BUNDLE BRANCH BLOCK (LEFT AND/OR RIGHT), VENTRICULAR SEPTAL DEFECT, AORTIC REGURGITATION, TRICUSPID REGURGITATION, AND PULMONARY HYPERTENSION. COMPLICATIONS REPORTED INCLUDED SURGICAL INTERVENTION, UNEXPECTED MEDICAL INTERVENTION (SNARE), HOSPITALIZATION, AORTIC REGURGITATION, THROMBOSIS, TRICUSPID REGURGITATION, HEART BLOCK, DEFORMATION, DEVICE EMBOLIZATION, RESIDUAL SHUNT; 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. B3: EVENT DATE WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE: ARTICLE TITLE: TRANSCATHETER CLOSURE OF VENTRICULAR SEPTAL DEFECTS AFTER UPFRONT TRANSVENOUS ANTEGRADE CANNULATION FROM THE RIGHT VENTRICLE.

    Description of Event or Problem · 0

    THE ARTICLE, "TRANSCATHETER CLOSURE OF VENTRICULAR SEPTAL DEFECTS AFTER UPFRONT TRANSVENOUS ANTEGRADE CANNULATION FROM THE RIGHT VENTRICLE", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY TO EVALUATE THE FEASIBILITY, SAFETY, AND EFFICACY OF UPFRONT ANTEGRADE CANNULATION AND CLOSURE FOR VENTRICULAR SEPTAL DEFECT (VSD). DEVICES INCLUDED IN THE STUDY WERE HEARTR DUCT OCCLUDER, AMPLATZER DUCT OCCLUDER II, KONAR MULTIFUNCTION OCCLUDER, AMPLATZER MUSCULAR VSD OCCLUDER, PICCOLO OCCLUDER, AND UNKNOWN. THE ARTICLE CONCLUDED THAT UPFRONT TRANSVENOUS VSD CANNULATION SIMPLIFIES TRANSVENOUS TRANSCATHETER CLOSURE (TCC) BY ELIMINATING THE NEED FOR ARTERIAL ACCESS AND AVL FORMATION, PARTICULARLY SUCCESSFUL IN SMALL PATIENTS WITH LARGE DEFECTS. [THE PRIMARY AND CORRESPONDING AUTHOR WAS KOTHANDAM SIVAKUMAR, DEPARTMENT OF PEDIATRIC CARDIOLOGY, INSTITUTE OF CARDIO VASCULAR DISEASES, MADRAS MEDICAL MISSION, 4A DR J J, NAGAR, MOGAPPAIR, CHENNAI 600037, INDIA, WITH CORRESPONDING EMAIL: [email protected]] THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2019 TO DECEMBER 2023. A TOTAL OF 147 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 69 (46.9%) RECEIVED AN ABBOTT DEVICE AS FINAL DEVICE IMPLANTED. IN THE UPFRONT ANTEGRADE GROUP: THE AVERAGE AGE WAS 55 MONTHS, THE AVERAGE WEIGHT WAS 15.8KG, AND THE GENDER RATIO WAS EVEN (58 OUT OF 116 WERE MALE). IN THE ARTERIOVENOUS LOOP GROUP: THE AVERAGE AGE WAS 121 MONTHS, THE AVERAGE WEIGHT WAS 27KG, AND THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED BUNDLE BRANCH BLOCK (LEFT AND/OR RIGHT), VENTRICULAR SEPTAL DEFECT, AORTIC REGURGITATION, TRICUSPID REGURGITATION, AND PULMONARY HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359813 AMPLATZER MUSCULAR VSD OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown