BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIGULLA FLEX II ASD

    MDR report key: 23495799 · Received November 7, 2025

    Report

    Report Number
    3014616394-2025-00031
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    October 16, 2025
    Report Date
    July 11, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182520734
    PMA / PMN Number
    P200032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE BATCH RECORDS AND INSPECTION PROTOCOLS REVEALED NO DEVIATION. MEDICAL EXPERT ASSESSMENT: BALLOON SIZING WAS NOT DONE BUT IS REQUIRED BEFORE IMPLANTATION TO · MAKE THE MOSTLY OVAL HOLES ROUND AND · PRESS THE FLOPPY PART AWAY AND · SHOW THE STABLE PART IF VERY FLOPPY RIMS SHOW TEARS ETC. THIS IS NOT A PROBLEM OF A DEVICE BUT DUE TO THE FLOPPINESS OF THE TISSUE. ACCORDING TO THE TREATING PHYSICIAN, THIS MAY HAVE RESULTED FROM ANATOMICAL FACTORS PARTICULARLY A FLOPPY RIM, WHICH COULD HAVE CONTRIBUTED TO TISSUE TEARING DURING THE PROCEDURE. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE COMPLEXITY OF THE PATIENT ANATOMY CANNOT BE EXCLUDED AS CONTRIBUTING FACTOR OF THIS PARTICULAR COMPLAINT CASE. IN THE LIGHT OF ALL AVAILABLE INFORMATION, THE ROOT CAUSE HAS BEEN TRACED TO NON-DEVICE RELATED FACTORS.

    Description of Event or Problem · 0

    TISSUE DAMAGE: - PATIENT HAD A POSTERIOR RIM AND SHORT / NEARLY ABSENT AORTIC RIM - DEFECT SIZE OF 24MM MEASURED BY MEANS OF TEE AND TTE - ASD27 SELECTED BUT COULD NOT BE POSITIONED PROPERLY IN DEFECT - DEVICE REMOVED - VERY FLOPPY POSTERIOR RIM WAS IDENTIFIED, MAKING DEVICE STABILIZATION DIFFICULT - DEGREE OF RIM LAXITY WAS NOT CLEARLY IDENTIFIABLE ON PREPROCEDURAL IMAGING (TEE) - ASD30 SELECTED BUT COULD ALSO NOT BE POSITIONED PROPERLY - DEVICE REMOVED - DEFECT RE-ASSESSMENT REVEALED DEFECT SIZE OF 34MM (DEFECT ENLARGED) - ASSUMPTION IS POSTERIOR RIM MAY HAVE TORN DURING THE PREVIOUS ATTEMPTS - PATIENT WAS SENT TO SURGERY FOR DEFECT CLOSURE ACCORDING TO THE PHYSICIAN, THIS MAY HAVE RESULTED FROM ANATOMICAL FACTORS PARTICULARLY A FLOPPY RIM, WHICH COULD HAVE CONTRIBUTED TO TISSUE TEARING DURING THE PROCEDURE. EVENT REFLECTS MISMATCH BETWEEN ANATOMICAL CONDITION BEFORE AND DURING PROCEDURE IMAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180769 FIGULLA FLEX II ASD ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD27 2447292706 04260182520734

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other