BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 20152851 · Received September 5, 2024

    Report

    Report Number
    3014616394-2024-00011
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    July 15, 2024
    Report Date
    January 29, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182520680
    PMA / PMN Number
    P200032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE BATCH RECORD AND INSPECTION PROTOCOLS OF THE REPORTED FLEX II ASD REVEALED NO DEVIATION. NO OTHER COMPLAINT EXISTS FROM THE REPORTED LOT REGARDING THE SAME COMPLAINT REASON. ALL QC CRITERIA WERE WITHIN SPECIFICATION ACCORDING TO THE BATCH RECORD. THE DEVICE WAS NOT RETURNED FOR FURTHER INVESTIGATION. THE REPORTED CASE WAS THOROUGHLY REVIEWED BASED ON THE PROVIDED INFORMATION AND THE AVAILABLE TEES. BASED ON THE MEDICAL EXPERT ASSESSMENT, IT WAS CONCLUDED THAT THE DEVICE WAS PROPERLY POSITIONED AND SECURELY IMPLANTED, AS CONFIRMED BY THE FINDINGS OF THE IMMEDIATE POST-PROCEDURAL ECHOCARDIOGRAPHY. HOWEVER, FURTHER IMAGING SUGGESTED THE DEVICE MAY HAVE BEEN IN CONTACT WITH THE POSTERIOR SUPERIOR ATRIAL WALL. ADDITIONALLY, A SIGNIFICANT PERICARDIAL EFFUSION WAS OBSERVED IN THE TEE IMAGES FOLLOWING ONE DAY AFTER THE PROCEDURE. SURGICAL FINDINGS, AS PROVIDED BY THE CUSTOMER, REVEALED A LARGE LACERATION IN THE ATRIAL WALL, CHARACTERIZED BY TISSUE EDEMA AND BLOOD STAINING, CONSISTENT WITH TISSUE EROSION CAUSED BY CONTINUOUS FRICTION RATHER THAN A SHARP PUNCTURE. THE ATRIAL TISSUE APPEARED FRIABLE AND DAMAGED, INDICATING PROLONGED MECHANICAL INTERACTION BETWEEN THE DEVICE AND THE TISSUE. THE ABSENCE OF A CLEAR PUNCTURE WOUND CORROBORATES THE HYPOTHESIS OF CHRONIC FRICTIONAL TRAUMA RATHER THAN AN ACUTE MECHANICAL FAILURE. ACCORDING TO THE FEEDBACK FROM THE MEDICAL EXPERT, IT APPEARS THAT THE EDGES OF THE FLEX II ASD OCCLUDER MAY HAVE APPLIED LOCALIZED PRESSURE ON THE POSTERIOR SUPERIOR ATRIAL WALL AND LIKELY CAUSED TISSUE IRRITATION, LEADING TO EVENTUAL EROSION. NO INTRA-PROCEDURAL TOE WAS ADDITIONALLY AVAILABLE TO MONITOR DEVICE PLACEMENT EFFECTIVELY AND IDENTIFY OR ADDRESS ANY POTENTIAL MALPOSITIONING DURING DEPLOYMENT. FURTHERMORE, THE SIZE OF THE FLEX II ASD (15 MM) WAS SELECTED BASED ON BALLOON SIZING AND TEE MEASUREMENTS, WHICH INDICATED A DEFECT DIAMETER OF 15 MM (BORDERLINE DIAGNOSIS AS RECOMMENDED FOR ASD15). BASED ON THE AVAILABLE INFORMATION, IT CAN BE DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS NOT RELATED TO THE FLEX II ASD OCCLUDER ITSELF. THE EROSION AND SUBSEQUENT LACERATION OF THE ATRIAL WALL IN THIS CASE WERE LIKELY THE RESULT OF CONTINUOUS FRICTION BETWEEN THE FLEX II ASD OCCLUDER AND THE POSTERIOR SUPERIOR ATRIAL WALL. NONETHELESS, TISSUE EROSION FOLLOWING FLEX II ASD IMPLANTATION IS A WIDELY RECOGNIZED AND WELL DOCUMENTED PHENOMENON, AS DESCRIBED IN THE CORRESPONDING IFU. THE IFU ALSO INCLUDES WARNINGS AND PRECAUTIONS IN ORDER MITIGATE THE RISK OF EROSION.

    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

    IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF THIS 15 MILLIMETER (MM) ATRIAL SEPTAL DEFECT (ASD) OCCLUDER THE DEFECT WAS MEASURED TO 15 MM VIA A SIZING BALLOON AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). A NINE FRENCH (F) SHEATH WAS USED AND THE OCCLUDER WAS SUCCESSFULLY IMPLANTED UNDER TEE MONITORING WITHOUT ISSUE. IN THE MORNING ONE DAY AFTER IMPLANT THE PHYSICIAN EXAMINED THE PATIENT INCLUDING AN ECHOCARDIOGRAM (ECHO) AND CONFIRMED THE RESULTS WERE SATISFACTORY AND THE PATIENT WAS DISCHARGED. THE EVENING ONE DAY AFTER IMPLANT THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT IN A STATE OF SHOCK WITH SEVERE CHEST PAIN, LOW BLOOD PRESSURE AND PERICARDIAL FLUID RESULTING IN CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED AND ECHO CONFIRMED A DECREASE IN THE EFFUSION. THE PATIENT CONDITION STABILIZED AND ASPIRIN WAS STOPPED. TWO DAYS AFTER IMPLANT OPEN HEART SURGERY WAS PERFORMED. DURING SURGERY A PERICARDIAL BLOOD DRAINAGE WAS PERFORMED. AN EXTERNAL EXAMINATION OF THE HEART REVEALED NUMEROUS TISSUE BRUISES AND CONFIRMED THERE WERE NO ACTIVE BLEEDING OR PERFORATION. A HOLE WAS IDENTIFIED IN THE WALL OF THE RIGHT ATRIUM NEAR THE ROOT OF THE AORTA. THE DEVICE WAS REMOVED AND THE HOLE IN THE RIGHT ATRIUM AND THE ASD WERE BOTH SUTURED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS TRANSFERRED TO THE PEDIATRIC INTENSIVE CARE UNIT UNDER SEDATION WITH STABLE HEMODYNAMICS. THE PATIENT RECOVERED AND WAS DISCHARGED IN GOOD CONDITION. PER THE PHYSICIAN IT WAS UNCERTAIN IF THE HOLE IN THE WALL OF THE RIGHT ATRIUM WAS CAUSED BY THE OCCLUDER OR IF A PUNCTURE WAS MADE BY MISTAKE DURING THE IMPLANT PROCEDURE FROM THE SHEATH OR SIZING BALLOON. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1888560 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD15 04260182520680

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male Life Threatening| R| H