BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIGULLA FLEX II ASD

    MDR report key: 23231844 · Received October 7, 2025

    Report

    Report Number
    3014616394-2025-00021
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 7, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    PMA / PMN Number
    P200032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION: ADOLESCENT (13-17 YEARS), MALE, WEIGHT >50-60 KG. CLINICAL EVENT: · A TEENAGE PATIENT WAS REFERRED FOR CLOSURE OF A PRESUMED SMALL CENTRAL ATRIAL SEPTAL DEFECT. · DURING IMPLANT, IT WAS DETERMINED THAT THE DEFECT REPRESENTED A PFO/TUNNEL-LIKE MORPHOLOGY. · BALLOON SIZING AND ECHOCARDIOGRAPHY MEASURED THE DEFECT AT APPROXIMATELY 8-9 MM. DEVICE USE AND OBSERVATIONS: · AN INITIAL 10.5 MM DEVICE WAS DEPLOYED. · AFTER DEPLOYMENT, THE WAIST APPEARED COMPRESSED WITH RELATIVELY SEPARATED DISCS. · TEE DEMONSTRATED NO RESIDUAL SHUNT IMMEDIATELY POST-DEPLOYMENT. · FLUOROSCOPY SUGGESTED THE DEVICE WAS RELATIVELY STABLE AT THAT TIME. RETROSPECTIVE FINDINGS: · UPON REVIEW OF STILL IMAGING, IT IS LIKELY THAT THE RIGHT ATRIAL DISC HAD NOT CAPTURED THE ANTERIOR RIM ADEQUATELY. · THIS MAY HAVE RESULTED IN DEVICE EMBOLIZATION SHORTLY AFTER RELEASE, DESPITE INITIAL STABILITY ON IMAGING. CLINICAL SIGNIFICANCE & LEARNING POINTS: · THIS CASE HIGHLIGHTS THE CHALLENGE OF DEVICE CLOSURE IN PFO/TUNNEL-LIKE ATRIAL SEPTAL DEFECTS, WHERE DEVICE CONFIGURATION AFTER RELEASE MAY NOT CONFORM TO EXPECTATIONS. · SMALL DEFECTS ARE NOT NECESSARILY STRAIGHT FORWARD, DEFINING THE ANATOMY IS KEY. · THE EVENT SUGGESTS THAT IN SUCH ANATOMIES, CAREFUL RECONSIDERATION OF DEVICE SELECTION AND SIZING IS WARRANTED, INDEPENDENT OF BRAND OR SPECIFIC DEVICE USED. · ATTENTION SHOULD BE DIRECTED TO RIM CAPTURE AND DEVICE CONFIGURATION BEFORE RELEASE TO MINIMIZE EMBOLIZATION RISK. CONCLUSION: · DEVICE EMBOLIZATION WOULD HAVE BEEN THE CASE WITH ANY OTHER SELF CENTERING DEVICE DUE TO THE ANATOMY. · ROOT CAUSES INCLUDE ANATOMICAL COMPLEXITY (PFO/TUNNEL MORPHOLOGY) AND SUBOPTIMAL RIM CAPTURE RATHER THAN AN INHERENT DEVICE MALFUNCTION. · CONSIDER DIFFERENT DEVICE OR EARLY EVALUATION OF DEVICE IF CONFIGURATION IS NOT THE EXPECTED BY THE END OF THE CASE.

    Description of Event or Problem · 0

    DEVICE DISLOCATION/ EMBOLIZATION: - DEVICE EMBOLIZED TO THE AORTA WAS FOUND ON A PRE-DISCHARGE ECHO ROUGHLY 2 HOURS AFTER PLACEMENT. - DEVICE WAS SUCCESSFULLY RETRIEVED WITH A 9F SHEATH AND SNARE. - DEFECT WAS LATER DETERMINED TO BE A LONG TUBULAR PFO AND SUCCESSFULLY CLOSED WITH A 25MM CRIBRIFORM DEVICE. - TEE MEASURED 8MM AND BALLOON SIZING MEASURED 13.5MM. - ADOLESCENT (13-17 YEARS) MALE, WEIGHT >50-60 KG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2692402 FIGULLA FLEX II ASD ASD OCCLUDER OZG OCCLUTECH GMBH 37ASD10 2412371020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Life Threatening| R