BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIGULLA FLEX II ASD OCCLUDER PROCEDURE PACK

    MDR report key: 21803909 · Received April 9, 2025

    Report

    Report Number
    3012613541-2025-00001
    Event Type
    Injury
    Date Received
    April 9, 2025
    Date of Event
    March 9, 2025
    Report Date
    December 11, 2025
    Manufacturer
    OCCLUTECH INTERNATIONAL AB
    Product Code
    OZG
    PMA / PMN Number
    P200032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE BATCH RECORD AND INSPECTION PROTOCOLS OF THE REPORTED DEVICE REVEALED NO DEVIATION. ALL QC CRITERIA WERE WITHIN SPECIFICATION ACCORDING TO THE BATCH RECORD. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. THE VISUAL INVESTIGATION DID NOT REVEAL ANY CLEAR DEVIATIONS, EXCEPT THE DISC DAMAGE, WHICH WAS MENTIONED BY THE PHYSICIAN AND WHICH HAPPENED DURING THE EXTRACTION OF THE DEVICE. HOWEVER, AS THE DEVICE WAS HIGHLY CONTAMINATED (TISSUE AROUND THE DEVICE), A MORE DETAILED INVESTIGATION WAS NOT POSSIBLE. IT MUST BE NOTED THAT DUE TO THE IMPLANTATION, DEVICE REMAINING INSIDE THE PATIENT, THEN EXTRACTION, THE RETURNED DEVICE CONDITIONS DO NOT REPRESENT THE CONDITIONS AT THE TIME OF DEVICE RELEASE TO THE MARKET. BASED ON THE AVAILABLE INFORMATION, IT CAN BE CONCLUDED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS NOT DIRECTLY RELATED TO THE FLEX II ASD OCCLUDER ITSELF. TISSUE EROSION FOLLOWING FLEX II ASD IMPLANTATION IS A WELL-KNOWN INHERENT RISK OF THE DEVICE. FURTHERMORE, THE DEFICIENCY OF RIMS SIGNIFICANTLY INCREASED THE RISK OF AN ADVERSE OUTCOME.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: PRE-PROCEDURAL TOE SHOWED ASD WITH ESTIMATED DIMENSIONS 2.3X 2.08, DEFICIENT RETROAORTIC RIM, SEVERELY DILATED RV, NO EVIDENCE OF PULM HYPERTENSION. CATH (B)(6) 2024: MILDLY ELEVATED FILLING PRESSURES (MEAN 10MMHG), HEMODYNAMICS OTHERWISE UNREMARKABLE. QP/QS 2.4:1 UNSTRETCHED DIAMETER 2.2X 2.1. BALLOON SIZED WITH 34 SIZING BALLOON AT 27MM (TOE AND FLUORO). FIGULLA FLEX 27 INTRODUCED AND DEPLOYED. CHECKED AND RELEASED. UNEVENTFUL NIGHT. WELL AND ECHO CHECK SATISFACTORY NEXT DAY, DISCHARGED ON ASPIRIN FOR 6 MONTHS. SEEN IN CLINIC 23 JAN 2025. SYMPTOMATICALLY IMPROVED - LESS BREATHLESS WITH WALKING. ECHO FINE - NO EFFUSION, RV DILATION NOW MILD, DEVICE IN SITU APPROPRIATELY. COLLAPSED 9 MARCH 2025 IN SHOPPING MALL, CHEST PAIN, WORSE WITH INSPIRATION. AMBULANCE NOTED FEATURES OF SHOCK. TRANSPORTED TO ED, HYPOTENSIVE AND DIAPHORETIC. BEDSIDE USS SHOWED LARGE PERICARDIAL EFFUSION, PERICARDIOCENTESIS ACUTELY - FRESH BLOOD. CT PERFORMED TO RULE OUT DISSECTION. DISCUSSION WITH OPERATOR - ADVISED NEEDED EXPLORATION ACUTELY FOR LIKELY DEVICE EROSION. IN OR SURGEON NOTED "THERE WAS A LARGE HAEMORRHAGIC PERICARDIAL EFFUSION WITH CLOTS AROUND THE RV RESULTING IN TAMPONADE PHYSIOLOGY. BLOOD PRESSURE IMPROVED WITH OPENING THE PERICARDIUM. THE 27 MM OCCLUTECH DEVICE WAS PERFECTLY DEPLOYED AND WELL SEATED WITH GOOD ENDOTHELISATION OF THE AORTIC AND POSTERIOR RIMS ON THE RIGHT ATRIAL SIDE AND EXCELLENT ENDOTHELIALISATION THROUGHOUT THE LEFT ATRIAL APPOSITION. THE ASD ITSELF HAD A DEFICIENT AORTIC RIM BUT NO MORE SO THAN USUAL. THE TRICUSPID VALVE WAS NOT INSPECTED. I DID NOT OPEN THE AORTIC ROOT BUT ON THE EXPLORATION BETWEEN THE NONCORONARY SINUS AND RIGHT ATRIUM THERE WAS AN INDURATED AREA THAT HAD A PERFORATION, WHICH WHEN PROBED LED TO THE BULK OF THE ASD DEVICE. I COULD NOT DIRECTLY PROBE INTO THE ATRIUM BUT I SUSPECT THAT BLOOD WAS TRACKING THROUGH THE DEVICE AND OUT THE PERFORATION" PATIENT REMAINS INPATIENT BUT MAKING A GOOD RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665124 FIGULLA FLEX II ASD OCCLUDER PROCEDURE PACK ASD OCCLUDER OZG OCCLUTECH INTERNATIONAL AB 29ASD27 2045292716

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Hospitalization| L