BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 11402130 · Received March 2, 2021

    Report

    Report Number
    2135147-2021-00075
    Event Type
    Injury
    Date Received
    March 2, 2021
    Report Date
    March 14, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, 936 CONSECUTIVE PATIENTS UNDERWENT CLOSURE OF OVAL FOSSA DEFECTS OVER A 6 YEAR PERIOD WHICH STARTED IN (B)(6) 2013; 374 PATIENTS WERE IMPLANTED WITH AN AMPLATZER SEPTAL OCCLUDER. A TOTAL OF 52 DEVICE DEFORMATIONS WERE REPORTED IN PATIENTS WITH AN AMPLATZER SEPTAL OCCLUDER. TWO PATIENTS DEVELOPED TRANSIENT SUPRAVENTRICULAR TACHYCARDIA DURING DEVICE MANIPULATION WITHIN THE ATRIUM AND A FEW PATIENTS HAD THE DEVICE SUCCESSFULLY SNARED AS THE PHYSICIAN INADVERTENTLY UNSCREWED THE DEVICE FROM THE DELIVERY CABLE DURING DEVICE MANIPULATION. 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.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    THE ARTICLE, " COBRA-HEAD AND OTHER SHAPE-MEMORY ABNORMALITIES OF NITINOL ATRIAL SEPTAL OCCLUDERS: INCIDENCE, PREDISPOSING FACTORS, AND OUTCOMES", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO EVALUATE THE DEFORMATION OF NITINOL ATRIAL SEPTAL OCCLUDERS IN ALL CONSECUTIVE DEVICE CLOSURES OF ATRIAL SEPTAL DEFECTS. AMPLATZER SEPTAL OCCLUDER (ABBOTT), CERA SEPTAL OCCLUDER (LIFETECH SCIENTIFIC) AND FIGULLA SEPTAL OCCLUDER (OCCLUTECH INTERNATIONAL) WERE ASSOCIATED WITH THE STUDY. THERE IS NO ALLEGATION OF MALFUNCTION OF THE ABBOTT DEVICE. THE PRIMARY AUTHOR OF THE ARTICLE IS BHUSHAN S. SONAWANE, DEPARTMENT OF PEDIATRIC CARDIOLOGY, INSTITUTE OF CARDIO-VASCULAR DISEASES, MADRAS MEDICAL MISSION, CHENNAI, INDIA. THE CORRESPONDENCE AUTHOR IS KOTHANDAM SIVAKUMAR, MD, DM, HEAD OF DEPARTMENT OF PEDIATRIC CARDIOLOGY, MADRAS MEDICAL MISSION, 4A DR J. J. NAGAR, MOGAPPAIR, CHENNAI 600037, INDIA WITH THE CORRESPONDING EMAIL: [email protected]. THE ARTICLE REPORTED THAT 936 CONSECUTIVE PATIENTS UNDERWENT CLOSURE OF OVAL FOSSA DEFECTS OVER A 6-YEAR PERIOD COMMENCING FROM MAY 2013. THE AVERAGE AGE WAS 23.3 YEARS OLD, THE AVERAGE WEIGHT WAS 45KG AND THE MAJORITY OF THE PATIENTS WERE FEMALE. 374 PATIENTS WERE IMPLANTED WITH AN AMPLATZER SEPTAL OCCLUDER. A TOTAL OF 52 DEVICE DEFORMATIONS WERE REPORTED IN PATIENTS WITH AN AMPLATZER SEPTAL OCCLUDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295044 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention