BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 19092929 · Received April 11, 2024

    Report

    Report Number
    3014616394-2024-00004
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    March 11, 2024
    Report Date
    June 6, 2024
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182520758
    PMA / PMN Number
    P200032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PATIENT AGE AND WEIGHT ARE UNKNOWN. CONCLUSION: A THROMBUS FORMATION WAS REPORTED. THE DEVICE WAS RECEIVED FOR ANALYSIS AND PASSED ALL FUNCTIONAL TESTING. NO THROMBUS WAS OBSERVED DURING THE VISUAL INSPECTION. THE VISUAL INSPECTION REVEALED THAT THE KNOT FROM THE SEWING PATCH WAS OUTSIDE THE WIRE MESH OF THE RIGHT ATRIAL (RA) DISC. THE PHYSICIAN WAS CONSULTED REGARDING THIS OBSERVATION AND STATED THAT IT IS POSSIBLE THE KNOT WAS MISTAKEN FOR A THROMBUS, THOUGH IT COULD NOT BE CONFIRMED FOR CERTAIN. THE PHYSICIAN CONFIRMED THAT THERE WAS NO KNOT OBSERVED DURING THE VISUAL INSPECTION PRIOR TO THE IMPLANTATION PROCEDURE. 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. PACKAGING AND SHIPPING WERE ACCORDING TO PROCESS. THE ENVIRONMENTAL CONDITIONS WERE WITHIN LIMITS DURING STORAGE. THE DEVICE PASSED THE VISUAL TEST AT THE TIME OF PRODUCTION WHICH INCLUDES CONFIRMING THE SEWING KNOT IS STORED UNDER THE MESH. IN ADDITION, THE PHYSICIAN CONFIRMED THAT NO KNOT WAS OBSERVED PRIOR DURING THE PRE-IMPLANT INSPECTION. HENCE IT IS LIKELY THAT THE SEWING KNOT MOVED OUTSIDE THE MESH DUE TO THE HANDLING/IMPLANTATION FORCES. IT IS LIKELY THAT THE KNOT WAS MISTAKENLY IDENTIFIED AS A THROMBUS. A MEDICAL EXPERT WAS CONSULTED AND CONFIRMED IT WOULD BE POSSIBLE THAT EITHER A SEWING KNOT OUTSIDE THE MESH OR THE WELDING BALL OF THE OCCLUDER COULD BE MISTAKEN FOR A THROMBUS. HOWEVER, IT CANNOT BE CONFIRMED DEFINITIVELY, AND BASED ON THE INFORMATION RECEIVED A ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF THIS 36 MILLIMETER (MM) ATRIAL SEPTAL DEFECT (ASD) OCCLUDER, THE DEFECT WAS MEASURED TO 30MM WITH A SIZING BALLOON. A BALD AORTA WAS NOTED. DURING THE IMPLANTATION ATTEMPT THERE WAS DIFFICULTY DEPLOYING THE OCCLUDER. THE OCCLUDER WAS REMOVED FROM THE BODY AND A THROMBUS WAS OBSERVED. THE OCCLUDER WAS WASHED WITH SALINE BUT THE THROMBUS COULD NOT BE REMOVED. A NEW 36 MM OCCLUDER AND DELIVERY SET WERE USED TO COMPLETE THE PROCEDURE. IT WAS NOTED THAT THE DEPLOYMENT DIFFICULTY WAS DUE TO THE LARGE DEFECT SIZE WHICH RESULTED IN STANDARD TECHNIQUES BEING UNSUCCESSFUL. BALLOON ASSISTED TECHNIQUES WERE REQUIRED. ANTI-BLOOD CLOTTING MEDICATION WAS GIVEN PRIOR TO THE PROCEDURE. THE AVERAGE CLOTTING TIME (ACT) MEASURED DURING THE PROCEDURE WAS 200 SECONDS OR MORE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125498 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD36 04260182520758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Life Threatening