BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER CRIBRIFORM OCCLUDER

    MDR report key: 12545537 · Received September 29, 2021

    Report

    Report Number
    2135147-2021-00391
    Event Type
    Injury
    Date Received
    September 29, 2021
    Report Date
    September 29, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED IN A RESEARCH ARTICLE, COMPLICATIONS FROM ATRIAL SEPTAL DEFECT CLOSURE INCLUDED ATRIOVENTRICULAR BLOCK, DEVICE EXPLANT, DEVICE EMBOLIZATION, SURGICAL CLOSURE OF THE DEFECT, SUPRAVENTRICULAR TACHYCARDIA, TRANSIENT ATRIOVENTRICULAR DISASSOCIATION, MITRAL REGURGITATION, HEMATOMA, BLEEDING AND INSIGNIFICANT EXTRASYSTOLES. 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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    RELATED MANUFACTURING REFERENCE NUMBERS 2135147-2021-00393 AND 2135147-2021-00390. THE ARTICLE, "COMPARISON OF TRANSCATHETER ATRIAL SEPTAL DEFECT CLOSURE BETWEEN CHILDREN WEIGHING LESS THAN 15 KG AND CHILDREN WEIGHING 15 TO 20 KG", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO ASSESS THE RELIABILITY AND EFFICACY OF TRANSCATHETER ATRIAL SEPTAL DEFECT (ASD) CLOSURE IN CHILDREN WEIGHING LESS THAN 15 KG RELATIVE TO TRANSCATHETER ASD CLOSURE IN CHILDREN WEIGHING 15 TO 20 KG, WHICH IS THE RECOMMENDED WEIGHT FOR GENERAL SURGICAL CLOSURE. THE AMPLATZER ATRIAL SEPTAL OCCLUDER, AMPLATZER MULTIFENESTRATED SEPTAL OCCLUDER, AMPLATZER PATENT FORAMEN OVALE OCCLUDER(ST JUDE MEDICAL, PLYMOUTH, MN, USA), THE LIFETECH CERAFLEX ATRIAL SEPTAL OCCLUDER (LIFETECH SCIENTIFIC CO LTD, SHENZHEN, CHINA), THE OCCLUTECH FIGULLA FLEX II ATRIAL SEPTAL OCCLUDER (OCCLUTECH AB, HELSINGBORG, SWEDEN), THE GORE ATRIAL SEPTAL OCCLUDER (WL GORE & ASSOCIATES, INC, FLAGSTAFF, AZ, USA), THE BIOSTAR ATRIAL SEPTAL OCCLUDER (NMT MEDICAL INC, BOSTON, MASS), AND THE COCOON ATRIAL SEPTAL OCCLUDER (VASCULAR INNOVATIONS CO LTD, NONTHABURI, THAILAND) ARE DEVICES THAT WERE ASSOCIATED WITH THE STUDY. THE ARTICLE CONCLUDED THE TRANSCATHETER CLOSURE OF SECUNDUM ASDS IN SMALL CHILDREN IS FEASIBLE AND IS NOT ASSOCIATED WITH A GREATER RISK OF SIGNIFICANT COMPLICATIONS. [THE AUTHOR AND CORRESPONDING AUTHOR OF THIS ARTICLE IS OSMAN BASPINAR, MD; DEPARTMENT OF PEDIATRIC CARDIOLOGY, GAZIANTEP UNIVERSITY MEDICAL FACULTY, SEYRANTEPE, ABDULKADIR KONUKOGLU CD NO:1, 27080 SEHITKAMIL GAZIANTEP, TURKEY, WITH EMAIL OF [email protected]].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446421 AMPLATZER CRIBRIFORM OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention