BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 20113118 · Received August 30, 2024

    Report

    Report Number
    3014616394-2024-00010
    Event Type
    Injury
    Date Received
    August 30, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 30, 2024
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    PMA / PMN Number
    P200032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A4 PATIENT WEIGHT IS NOT AVAILABLE. CONCLUSION: AN EVENT OF A DEVICE EMBOLISM WAS REPORTED. THE DEVICE WAS NOT RETURNED THEREFORE NO VISUAL INSPECTION OR FUNCTION TESTING OF THE ACTUAL DEVICE COULD BE CONDUCTED. 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. PER THE PHYSICIAN THERE WAS NO DEVICE FAILURE. PER THE PHYSICIAN THE DEFECT WAS LARGE AND THE RIM WAS INSUFFICIENT, DESPITE EXTENDING AROUND THE FULL CIRCUMFERENCE. PER THE PHYSICIAN GIVEN THE SMALLER SIZE OF THE PATIENT'S HEART THE SEPTAL LENGTH DETERMINED THE IMPLANTABLE SIZE. BASED ON THE RIMS MEASUREMENTS PROVIDED, THE PATIENT HAD A SUPERIOR RIM SIZE OF 3.8 MM (< 5 MM) AND THE AORTIC, INFERIOR VENA CAVA AND POSTERIOR RIM SIZES OF 5 MM WHICH SERVES AS A BORDERLINE DIAGNOSIS. PER THE INSTRUCTIONS FOR USE (IFU) THIS IS A CONTRAINDICATION AND COULD LEAD TO DEVICE DISLOCATION. BASED ON THE INVESTIGATION FINDINGS A DEVICE-RELATED FAILURE COULD NOT BE DETERMINED. THE ROOT CAUSE OF THE EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF THIS 24 MILLIMETER (MM) ATRIAL SEPTAL DEFECT (ASD) OCCLUDER, THE DEFECT WAS MEASURED TO 22-23 MM VIA BALLOON SIZING. THE DEFECT WAS MEASURED TO 18.4 MM BY 20.8 MM VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). AFTER THE OCCLUDER WAS DEPLOYED THE FULL CIRCUMFERENCE WAS CHECKED WITH TEE. THE OCCLUDER STAYED IN PLACE DURING WIGGLING. BECAUSE PINCHING THE LOWER RIM NEAR 115 DEGRESS APPEARED TO BE WEAK, THE RIM WAS CHECKED THOROUGHLY AND CONFIRMED TO BE SECURELY PINCHED. THE OCCLUDER WAS DETACHED FROM THE IMPLANT ACCESSORY AND THE PROCEDURE WAS COMPLETED. AFTER AWAKENING FROM ANESTHESIA THE PATIENT DEVELOPED A COUGH AND AN ABNORMAL ELECTROCARDIOGRAM (ECG) OCCURRED. FLUOROSCOPY REVEALED THAT THE OCCLUDER HAD EMBOLIZED TO THE RIGHT ATRIAL SIDE. THE PATIENT WAS ANESTHETIZED AGAIN AND THE OCCLUDER WAS RETRIEVED PERCUTANEOUSLY WITH A SNARE CATHETER. A NEW (27 MM) ASD OCCLUDER WAS IMPLANTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107562 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD24

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Female Required Intervention| L