BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 25159256 · Received May 13, 2026

    Report

    Report Number
    3014616394-2026-00021
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 13, 2026
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    PMA / PMN Number
    P200032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF BATCH RECORDS DID NOT REVEAL ANY DEVIATIONS. THE COMPLAINED FLEX II ASD OCCLUDER MET ALL SPECIFICATIONS AT THE TIME OF ITS RELEASE TO THE MARKET. THERE WERE NO SIMILAR COMPLAINTS FROM THE SAME BATCH. THE COMPLAINED FLEX II ASD OCCLUDER WAS DISCARDED BY THE HOSPITAL, THEREFORE, IT WAS NOT RETURNED FOR FURTHER INVESTIGATIONS. ACCORDING TO THE INFORMATION FROM THE CUSTOMER, THE PATIENT DID NOT HAVE SUFFICIENT RIMS. HOWEVER, AS PER THE CORRESPONDING IFU, FLEX II ASD OCCLUDERS ARE CONTRAINDICATED FOR PATIENTS WITH INSUFFICIENT RIMS. THE DEVICE LIKELY EMBOLIZED BECAUSE THERE WASN'T ENOUGH RIM SUPPORT TO HOLD IT IN PLACE. WITH BOTH THE AORTIC AND SUPERIOR RIMS ABSENT, AND A RELATIVELY LARGE DEFECT, THE DEVICE DIDN'T HAVE STABLE ANCHORING AND WAS PRONE TO EMBOLIZE. EVEN IF IT LOOKED FINE INITIALLY, THE CONSTANT MOTION OF THE HEART LIKELY LED TO GRADUAL LOSS OF POSITION AND EVENTUAL EMBOLIZATION. IN THE LIGHT OF ALL INVESTIGATION FINDINGS, THE ROOT CAUSE OF THIS COMPLAINT HAS BEEN TRACED BACK TO NON-DEVICE RELATED FACTORS, SPECIFICALLY TO THE PATIENT ANATOMY/CONDITION.

    Description of Event or Problem · 0

    THE SUBJECT DEVICE WAS IMPLANTED ON (B)(6) 2026. DURING THE ONE-MONTH FOLLOW-UP, A CHEST X-RAY CONFIRMED THE DISLODGEMENT OF THE OCCLUDER. THE DISLODGED OCCLUDER WAS RETRIEVED PERCUTANEOUSLY USING A SNARE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302725 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD27 2446292709

    Patients

    Seq Age Sex Outcome Treatment
    1