BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM

    MDR report key: 20522774 · Received October 24, 2024

    Report

    Report Number
    2135147-2024-05267
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    January 1, 2008
    Report Date
    January 2, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: ARTICLE TITLED " TRANSCATHETER CLOSURE OF MULTIPLE SECUNDUM ATRIAL SEPTAL DEFECTS USING MULTIPLE OCCLUDER DEVICES: A COMPARATIVE EXPERIENCE BETWEEN PEDIATRIC AND ADULT PATIENTS". INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: ARTICLE TITLED " TRANSCATHETER CLOSURE OF MULTIPLE SECUNDUM ATRIAL SEPTAL DEFECTS USING MULTIPLE OCCLUDER DEVICES: A COMPARATIVE EXPERIENCE BETWEEN PEDIATRIC AND ADULT PATIENTS. " SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF AMPLATZER SEPTAL OCCLUDER WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING SYSTEMIC HYPERTENSION, ATRIAL FIBRILLATION, PULMONARY THROMBOEMBOLISM, VALVULAR PULMONARY STENOSIS, RIGHT PULMONARY ARTERY STENOSIS, AND PULMONARY HYPERTENSION. COMPLICATIONS REPORTED INCLUDED UNEXPECTED MEDICAL INTERVENTION (SNARE), ARRHYTHMIA, THROMBUS, DEVICE EMBOLIZATION, DEFORMATION (COBRA), RESIDUAL SHUNT, THROMBUS; 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 INCIDENTS COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    THE ARTICLE, "TRANSCATHETER CLOSURE OF MULTIPLE SECUNDUM ATRIAL SEPTAL DEFECTS USING MULTIPLE OCCLUDER DEVICES: A COMPARATIVE EXPERIENCE BETWEEN PEDIATRIC AND ADULT PATIENTS", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY ANALYSIS OF ALL CASES OF MULTIPLE ATRIAL SEPTAL DEFECTS (ASDS) MANAGED USING MORE THAN ONE ATRIAL SEPTAL OCCLUDER. DEVICES INCLUDED AMPLATZER CRIBRIFORM AND AMPLATZER SEPTAL OCCLUDER. THE ARTICLE CONCLUDED THAT USE OF MULTIPLE DEVICES FOR CLOSING MULTIPLE ATRIAL SEPTAL DEFECTS (MASDS) IS FEASIBLE WITH GOOD TECHNICAL SUCCESS. ECHOCARDIOGRAPHY AND BALLOON INTERROGATION ARE THE KEYS FOR SUCCESS. SIMULTANEOUS DEPLOYMENT IS OFTEN NEEDED AND SEQUENTIAL DELIVERY IS FEASIBLE RARELY IF THE DEFECTS ARE FAR APART. MINOR RESIDUAL LEAKS ARE COMMON BUT IMPROVE ON FOLLOW-UP. THERE ARE NO SIGNIFICANT NEW COMPLICATIONS ON LONG-TERM FOLLOW-UP. [THE PRIMARY AND CORRESPONDING AUTHOR WAS KOTHANDAM SIVAKUMAR, DEPARTMENT OF PEDIATRIC CARDIOLOGY, INSTITUTE OF CARDIOVASCULAR DISEASES, THE MADRAS MEDICAL MISSION, NO 4A, DR J J NAGAR, MOGAPPAIR, CHENNAI - 600 037, TAMIL NADU, INDIA, WITH CORRESPONDING E-MAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2008 TO DECEMBER 2019. A TOTAL OF 25 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH ALL RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 33.92 YEARS AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED SYSTEMIC HYPERTENSION, ATRIAL FIBRILLATION, PULMONARY THROMBOEMBOLISM, VALVULAR PULMONARY STENOSIS, RIGHT PULMONARY ARTERY STENOSIS, AND PULMONARY HYPERTENSION.

    Description of Event or Problem · 0

    THE ARTICLE, "TRANSCATHETER CLOSURE OF MULTIPLE SECUNDUM ATRIAL SEPTAL DEFECTS USING MULTIPLE OCCLUDER DEVICES: A COMPARATIVE EXPERIENCE BETWEEN PEDIATRIC AND ADULT PATIENTS", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY ANALYSIS OF ALL CASES OF MULTIPLE ATRIAL SEPTAL DEFECTS (ASDS) MANAGED USING MORE THAN ONE ATRIAL SEPTAL OCCLUDER. DEVICES INCLUDED AMPLATZER CRIBIFORM OCCLUDER, AMPLATZER SEPTAL OCCLUDER, FIGULLA SEPTAL OCCLUDER, CERA ASD OCCLUDER. THE ARTICLE CONCLUDED THAT USE OF MULTIPLE DEVICES FOR CLOSING MULTIPLE ATRIAL SEPTAL DEFECTS (MASDS) IS FEASIBLE WITH GOOD TECHNICAL SUCCESS. ECHOCARDIOGRAPHY AND BALLOON INTERROGATION ARE THE KEYS FOR SUCCESS. SIMULTANEOUS DEPLOYMENT IS OFTEN NEEDED AND SEQUENTIAL DELIVERY IS FEASIBLE RARELY IF THE DEFECTS ARE FAR APART. MINOR RESIDUAL LEAKS ARE COMMON BUT IMPROVE ON FOLLOW-UP. THERE ARE NO SIGNIFICANT NEW COMPLICATIONS ON LONG-TERM FOLLOW-UP. [THE PRIMARY AND CORRESPONDING AUTHOR WAS KOTHANDAM SIVAKUMAR, DEPARTMENT OF PEDIATRIC CARDIOLOGY, INSTITUTE OF CARDIOVASCULAR DISEASES, THE MADRAS MEDICAL MISSION, NO 4A, DR J J NAGAR, MOGAPPAIR, CHENNAI - 600 037, TAMIL NADU, INDIA, WITH CORRESPONDING E-MAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2008 TO DECEMBER 2019. A TOTAL OF 25 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH AN UNKNOWN AMOUNT RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 33.92 YEARS AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED SYSTEMIC HYPERTENSION, ATRIAL FIBRILLATION, PULMONARY THROMBOEMBOLISM, VALVULAR PULMONARY STENOSIS, RIGHT PULMONARY ARTERY STENOSIS, AND PULMONARY HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2562243 AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown