BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 23904716 · Received December 29, 2025

    Report

    Report Number
    3014616394-2025-00034
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    December 5, 2025
    Report Date
    December 29, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182520710
    PMA / PMN Number
    P200032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A THROMBUS WAS DETECTED ON THE DEVICE DURING THE IMPLANTATION PROCEDURE. THIS IS A KNOWN INHERENT RISK OF THE DEVICE AS LISTED IN THE INSTRUCTIONS FOR USE. THE INVESTIGATION OF THE RETURNED DEVICE REVEALED NO PROBLEM OR ANY FAILURE WITH THE DEVICE. THE REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATION. ALL CRITERIA WERE MET AS INTENDED. NO OTHER COMPLAINT WAS RECEIVED FROM THE SAME BATCH FOR A SIMILAR COMPLAINT REASON. EXPERT ASSESSMENT: ACCORDING TO THE MEDICAL EXPERT, THE DEVICE MAY HAVE CONTRIBUTED TO THROMBUS FORMATION, AS THE EVENT OCCURRED DURING THE IMPLANTATION PROCEDURE. THE MEDICAL EXPERT ALSO IDENTIFIED ADDITIONAL POTENTIAL CONTRIBUTING FACTORS, INCLUDING PROLONGED PROCEDURAL DURATION AND THE IMPLANTATION OF A FLEX II ASD OCCLUDER FOR CLOSURE OF A PFO DEFECT. IN THE MEDICAL EXPERT'S OPINION, THIS REPRESENTS A NON-STANDARD PROCEDURAL APPROACH, WHICH MAY HAVE CONTRIBUTED TO THE EVENT. THE ADMINISTRATION OF A HIGH DOSE OF HEPARIN IS ATYPICAL FOR THIS TYPE OF PROCEDURE, WHICH IS GENERALLY OF SHORT DURATION. THIS SUGGESTS THAT THE PROCEDURE MAY HAVE BEEN PROLONGED DUE TO INTRA-PROCEDURAL CHALLENGES OR DELAYS. ADDITIONALLY, THE USE OF AN ASD OCCLUDER FOR PFO CLOSURE IS NOT A STANDARD PROCEDURAL APPROACH AND MAY INDICATE THAT ADDITIONAL INTRA-PROCEDURAL ASSESSMENTS AND DECISION-MAKING OCCURRED, POTENTIALLY CONTRIBUTING TO EXTENDED PROCEDURAL TIME. BASED ON THE MEDICAL EXPERT'S ASSESSMENT, AN UNCONVENTIONAL PROCEDURAL COURSE, INCLUDING PROLONGED DURATION AND OFF-LABEL DEVICE USE, MAY HAVE ACTED AS ADDITIONAL RISK FACTORS ASSOCIATED WITH THE REPORTED EVENT. CONCLUSION: THE POTENTIAL ROOT CAUSE HAS BEEN TRACED BACK TO NON-DEVICE RELATED FACTORS, DUE TO THE PROLONGED PROCEDURE, WHICH MIGHT HAVE CAUSED BY USER ERROR OR COMPLEX PATIENT ANATOMY.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: DURING PLACEMENT OF DEVICE, THROMBUS WAS DETECTED IN THE ECHOCARDIOGRAM - DEVICE CAREFULLY PULLED INTO THE SHEET (INCLUDING THROMBUS) - ANOTHER DEVICE WAS IMPLANTED SUCCESSFULLY - ANTICOAGULATION TREATMENT (PATIENT WEIGHT 65KG): O HEPARIN 5000IU AT THE BEGINNING OF PROCEDURE O HEPARIN 4000IU AFTER SHEATH WAS PLACED IN LA O ACT VALUE UNKNOWN. NO PATIENT INJURY OR HARM OCCURRED. NO HEALTH CONSEQUENCE FOR THE PATIENT WERE REPORTED. THE PATIENT IS IN GOOD CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789237 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD24 2511292409 04260182520710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Life Threatening