BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 19333547 · Received May 16, 2024

    Report

    Report Number
    3014616394-2024-00005
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    April 11, 2024
    Report Date
    August 27, 2024
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182520666
    PMA / PMN Number
    P200032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: AN EVENT OF A DEVICE EMBOLISM WAS REPORTED. THE DEVICE WAS RECEIVED FOR ANALYSIS AND PASSED THE VISUAL INSPECTION. ALL CHARACTERISTICS WERE WITHIN SPECIFICATIONS. VISIBLE CONTAMINATION WAS NOTED. FUNCTIONAL TESTING REVEALED BALLOONING OF THE RIGHT ATRIAL (RA) DISC. AFTER REMOVAL OF RA PATCH THE BALLOONING WAS NO LONGER OBSERVED. IT WAS CONCLUDED THAT THE FORCES APPLIED WHILE RETRIEVING THE DEVICE MAY HAVE IMPACTED THE CONDITION OF THE DEVICE. A DEVICE HISTORY REVIEW (DHR) REVEALED NO DEVIATIONS. THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTS AND MET ALL SPECIFICATIONS AT THE TIME OF PRODUCTION. NO DEVIATIONS WERE FOUND IN THE INSPECTION PROTOCOL. PACKAGING AND SHIPPING WERE ACCORDING TO PROCESS. THE ENVIRONMENTAL CONDITIONS WERE WITHIN LIMITS DURING STORAGE. IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE DEFECTS. PER THE INSTRUCTIONS OF USE (IFU) THE MODEL OF ATRIAL SEPTAL DEFECT (ASD) OCCLUDER USED WOULD NOT BE RECOMMENDED FOR USE WITH A PATIENT WITH MULTIPLE DEFECTS. BASED ON THE DEVICE INVESTIGATION AND THE INFORMATION PROVIDED IT WAS CONCLUDED THAT THE DEVICE EMBOLISM WAS LIKELY DUE TO USE WITH A PATIENT THAT HAD MULTIPLE DEFECTS, WHICH IS CONTRAINDICATED IN THE IFU.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE REPORTED SIZE INCREASE OF THE LARGEST DEFECT AFTER SIZING WAS FROM 5.0 MM TO 9.6MM. THE DEVICE EMBOLIZATION WAS CONFIRMED VIA ECHOCARDIOGRAM (ECHO). A SNARE WAS USED TO EXPLANT THE DEVICE. IT WAS CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS DUE TO THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF THIS 10 MILLIMETER (MM) ATRIAL SEPTAL DEFECT (ASD) OCCLUDER, THE PATIENT WAS IN POOR CONDITION AND HAD MORE THAN ONE DEFECT. AFTER SIZING, THE MAJOR DEFECT INCREASED IN SIZE. WHILE IMPLANTING THE DEVICE THE PHYSICIAN NOTED THAT THERE WAS WIGGLE ROOM AND THE DEVICE WAS LOOSE DURING THE PULL TEST. THE DEVICE WAS RELEASED AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. APPROXIMATELY ONE HOUR FOLLOWING IMPLANT OF THE DEVICE, THE DEVICE WAS NO LONGER IN THE IMPLANTED LOCATION. THE PATIENT WAS RETURNED TO SURGERY AND THE DEVICE WAS EXPLANTED. THE PHYSICIAN ELECTED TO IMPLANT A PATENT FORAMEN OVALE (PFO) OCCLUDER TO PREVENT MAKING THE DEFECT LARGER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547145 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD10 04260182520666

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention