BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCCLUTECH ASD OCCLUDER PROCEDURE PACK

    MDR report key: 20350352 · Received October 2, 2024

    Report

    Report Number
    3006332832-2024-00003
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    September 16, 2024
    Report Date
    March 27, 2025
    Manufacturer
    OCCLUTECH HOLDING AG
    Product Code
    OZG
    UDI-DI
    07340175602054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). IMAGES OF THE PROCEDURE WERE SUBMITTED TO THE MANUFACTURER FOR EVALUATION. THROUGH THE PRE-PROCEDURE IMAGING, THE TOTAL SEPTAL LENGTH WAS 54 MM. WHILE PRELIMINARY IMAGING SUGGESTED FLOPPY RIMS, THE ENTIRE SEPTUM WAS FLOPPY ACCORDING TO THE GIVEN INFORMATION, INDICATING A THIN AND HYPERMOBILE ATRIAL SEPTUM. THE PATIENT'S ANATOMY POSED CHALLENGES FOR STANDARD DEVICE DEPLOYMENT DUE TO INSUFFICIENT TISSUE SUPPORT. MULTIPLE ADJUSTMENTS WERE REQUIRED TO ACHIEVE ADEQUATE SEALING, INCREASING MECHANICAL STRESS ON THE SEPTUM. THROUGH THE POST-PROCEDURAL IMAGING, IT WAS REVEALED THAT THE DEVICE MIGRATED TO THE PULMONARY SYSTEM. THE PRODUCT WAS RETRIEVED WITHOUT COMPLICATIONS AND A 40 MM GORE CARDIOFORM ASD WAS SUCCESSFULLY IMPLANTED, INSINUATING THE ORIGINAL DEVICE WAS POTENTIALLY UNDERSIZED FOR THE ANATOMY. ACCORDING TO THE MEDICAL EXPERT, IMAGING AND PROCEDURAL RECORDS CONFIRMED NO STRUCTURAL DEFECTS, MATERIAL FATIGUE, OR MANUFACTURING NON-CONFORMITIES IN THE REPORTED FLEX II ASD. A REVIEW OF THE BATCH RECORD WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NONCONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. THE PROCEDURE DEVIATED FROM THE INSTRUCTIONS FOR USE (IFU) BY EMPLOYING A "SANDWICHING" TECHNIQUE, WHICH IS NOT SPECIFIED FOR THE OCCLUTECH ASD OCCLUDER. THE OCCLUTECH ASD OCCLUDER IFU DOES NOT PROVIDE GUIDANCE FOR THE SIMULTANEOUS USE OF MULTIPLE OCCLUDERS. BASED ON THE INVESTIGATION, THE OFF-LABEL USE OF THE OCCLUTECH ASD OCCLUDER WAS IDENTIFIED AS THE PRIMARY CAUSE OF THE DEVICE DISLODGMENT. ADDITIONAL CONTRIBUTING FACTORS INCLUDED A FLOPPY SEPTUM AND THE USE OF A POTENTIALLY UNDERSIZED DEVICE, WHICH FURTHER INCREASED THE RISK OF EMBOLIZATION. THEREFORE, THE REPORTED DEFECT IS NOT CONFIRMED TO BE THE RESULT OF A MANUFACTURING PROCESS ISSUE. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED IN THE COMPLAINT DESCRIPTION: PIR EVENT DESCRIPTION: THE DEVICE WAS INTENDED TO BE "SANDWICHED" WITH AN ADDITIONAL OCCLUTECH ASD DEVICE, OFF-LABEL APPLICATION, IN A PATIENT WITH TWO DEFECTS. THE DEVICE HAD TO BE REPEATEDLY REPOSITIONED TO GET THE TWO DEVICES "SANDWICHED" TOGETHER AS THE PHYSICIANS INTENDED - TO AVOID A LEAK DEMONSTRATED BETWEEN THE TWO DEPLOYED DEVICES. THE PATIENT INITIALLY PRESENTED WITH A FLOPPY SEPTUM, ONE LARGE ASD AND A SECONDARY SMALLER ASD. DURING THE POST-PROCEDURE CLEAN-UP, THE DEVICE WAS NOTED TO HAVE EMBOLIZED TO THE PULMONARY SYSTEM WHEN ANESTHESIA NOTED PAC'S ON THE EKG. PATIENT WAS RE-PREPPED, AND A 20MM MULTI-SNARE DEVICE WAS USED AS A QUICK ATTEMPT TO SNARE THE ERRANT DEVICE. WHEN THAT FAILED, A 2.5MM GRASPER, AND AN ONO DEVICE WERE USED TO RETRIEVE AND REMOVE THE OCCLUTECH DEVICE. IMPLANTATION SITE INFORMATION: MULTIPLE ASD DEFECTS, FLOPPY SEPTUM. BALLOON STOP-FLOW TECHNIQUE, BUT BECAUSE OF BOTH DEFECTS THERE WERE TWO BALLOONS INFLATED AT ONCE. MEASUREMENTS WERE DONE OFF-SCREEN. INITIAL CASE REPORT SUBMITTED TO BIS NOTED THE DEFECT MEASURING 24MM. TOTAL SEPTAL LENGTH WAS 54MM, THE SEPTUM WAS NOTED ON PRELIMINARY IMAGING AS HAVING FLOPPY RIMS, BUT THE ENTIRE SEPTUM WAS DESCRIBED AS FLOPPY UPON CATH-LAB EVALUATION. METHOD OF DEFECT MEASUREMENT: TEE, SIZING BALLOON INDICATION THE PHYSICIAN WAS USING THE OCCLUDER FOR? MULTI-FENESTRATED ASD CLOSURES SUMMARY OF PIR EVENT [PLEASE SELECT APPLICABLE]: DEVICE DISLOCATION / EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007150 OCCLUTECH ASD OCCLUDER PROCEDURE PACK TRANSCATHETER SEPTAL OCCLUDER (ATRIAL) OZG OCCLUTECH HOLDING AG OPP23048 07340175602054

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention