BEUDAMED
    FDA Adverse Event Death Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 18810841 · Received February 29, 2024

    Report

    Report Number
    3014616394-2024-00001
    Event Type
    Death
    Date Received
    February 29, 2024
    Date of Event
    January 26, 2024
    Report Date
    July 3, 2024
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    PMA / PMN Number
    P200032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: AN EVENT OF EROSION, PERICARDIAL TAMPONADE, CARDIAC ARREST, AND DEATH WAS REPORTED. THE OCCLUDER WAS RECEIVED FOR ANALYSIS AND PASSED THE VISUAL INSPECTION AND ALL FUNCTIONAL TESTING. ALL CHARACTERISTICS WERE WITHIN SPECIFICATIONS. VISIBLE CONTAMINATION WAS NOTED. 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. REVIEW OF THE INCOMING INSPECTION OF RAW PRODUCTION MATERIALS REVEALED NO DEVIATIONS. THREE MEDICAL EXPERTS REVIEWED THE AVAILABLE DATA AND IMAGES. THE FIRST MEDICAL EXPERT STATED THAT THE IMPLANT PROCEDURE WAS CARRIED OUT COMPLETELY APPROPRIATE, INCLUDING THE ECHOCARDIOGRAM (ECHO) AND X-RAYS BEFORE AND AFTER THE PROCEDURE, ADEQUATE RIMS, EXACT SIZING, EXACT SIZE USED, WIGGLE, AND GOOD DOCUMENTATION BY ECHO AND FLUOROSCOPY. THE MEDICAL EXPERT CONFIRMED THERE WAS NOTHING THAT THEY WOULD RECOMMEND HAD BEEN DONE DIFFERENTLY. THE MEDICAL EXPERT NOTED THAT IN RETROSPECT THE RESPONSE TO THE HEMODYNAMIC DETERIORATION MAY HAVE BEEN INADEQUATE DESPITE THE CORRECT DIAGNOSIS. THE SECOND MEDICAL EXPERT NOTED A DISCREPANCY IN THE SIZE OF THE DEFECT ON THE SURGERY REPORT AND THE SIZE INDICATED BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). A DISCREPANCY IN THE BALLOON SIZING AND TEE SIZING WAS ALSO NOTED. THE MEDICAL EXPERT STATED THEY RECOMMEND REASSESSMENT AND RE-DOING BALLOON SIZING WHEN SUCH DISCREPANCIES ARE OBSERVED. THE SECOND MEDICAL EXPERT CONCLUDED THAT THE OCCLUDER WAS OVERSIZED. THE THIRD MEDICAL EXPERT STATED THE DISCREPANCY BETWEEN THE STATIC MEASUREMENT VIA TEE AND THE BALLOON SIZING WITH STOP FLOW COULD HAPPEN WITH ANEURYSMAL OR FLOPPY SUPPORTING ATRIAL TISSUE. PER THE EXPERT BECAUSE THE DEFECT WAS NOTED TO BE ANEURYSMAL THE SIZE OF OCCLUDER CHOSEN WOULD NOT BE CONSIDERED OVERSIZED. A REVIEW OF THE DIGITAL IMAGES PROVIDED BY THE CUSTOMER CONFIRMED THE DEFECT SIZING. PER THE IMAGES NO WAIST WAS DETECTED DURING BALLOON SIZING WHICH WOULD INDICATE THE DEVICE WAS NOT OVERSIZED. BASED ON THE INVESTIGATION FINDINGS A DEVICE-RELATED FAILURE COULD BE EXCLUDED. BASED ON THE INFORMATION THAT WAS RECEIVED A ROOT-CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. EROSION IS A KNOWN ADVERSE EVENT AND LISTED AS AN ADVERSE EVENT IN THE CORRESPONDING INSTRUCTIONS FOR USE (IFU). THE IFU 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 IMPLANT OF THIS 24MM ATRIAL SEPTAL DEFECT (ASD) OCCLUDER, SIZING WAS DETERMINED VIA 2-D ECHOCARDIOGRAPHY, FLUOROSCOPY, AND A 24 MM SIZING BALLOON. THE NATIVE ASD DIAMETER WAS MAX 15 MM AND THERE WAS AN AORTIC RIM OF 5 MM WITH SMALLER ASPECTS. A SECOND SMALL ASD CLOSE TO ASD/DD MULTI FENESTRATED AND AN ATRIAL SEPTAL ANEURYSM WERE ALSO NOTED. THE DEVICE WAS IMPLANTED WITH NO COMPLICATIONS. FOURTEEN DAYS FOLLOWING IMPLANT OF THE DEVICE A CARDIAC CHECK-UP SHOWED PROPER ASD CLOSURE WITH NO INDICATION OF COMPLICATIONS. FIFTEEN DAYS FOLLOWING IMPLANT OF THE DEVICE, EROSION OF THE AORTIC ROOT WITH BLEEDING WAS OBSERVED, WHICH RESULTED IN SEVERE PERICARDIAL TAMPONADE WITH CARDIAC ARREST. RESUSCITATION WAS PERFORMED AND TWO PERICARDIAL DRAINS WERE PLACED. THE PATIENT WAS TRANSPORTED TO THE IMPLANTING FACILITY AND OPEN-HEART SURGERY WAS PERFORMED TO EXPLANT THE DEVICE. NINETEEN DAYS FOLLOWING IMPLANT OF THE DEVICE THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908847 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD24

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Death