BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOTRAP III 5 MM X 37 MM

    MDR report key: 13608281 · Received February 26, 2022

    Report

    Report Number
    3011370111-2022-00023
    Event Type
    Malfunction
    Date Received
    February 26, 2022
    Date of Event
    December 26, 2021
    Report Date
    February 25, 2022
    Manufacturer
    NEURAVI LTD.
    Product Code
    NRY
    PMA / PMN Number
    K193063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE TARGETING AN OCCLUSION IN THE MIDDLE CEREBRAL ARTERY (MCA), THE 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE (ET307537 / 21F020AV) WAS SUCCESSFULLY USED FOR THE FIRST PASS; IT WAS INITIALLY REPORTED THAT THE EMBOTRAP III DEVICE COULD NOT BE INTRODUCED INTO THE HEADWAY® 21 MICROCATHETER (MICROVENTION) FOR A SECOND PASSAGE. FURTHER INFORMATION RECEIVED INDICATED THAT THE TARGET OCCLUSION WAS TREATED WITH THE EMBOTRAP III DEVICE WITH TWO PASSES. THE HARD CLOT WAS RECANALIZED WITH A COMPETITOR PRODUCT RESULTING IN A MODIFIED TREATMENT IN CEREBRAL INFARCTION (MTICI) SCORE OF 3. THE INFORMATION INDICATED THAT THE EMBOTRAP III DEVICE WAS USED TWO (2) TIMES WITHOUT PROBLEMS. ON THE THIRD ATTEMPT, THE EMBOTRAP III WAS INSERTED INTO THE INSERTION TOOL AND IT WAS INTRODUCED INTO THE MICROCATHETER. ADVANCEMENT INTO THE MICROCATHETER WAS ONLY POSSIBLE FOR A VERY LIMITED PORTION; FURTHER ADVANCEMENT WAS NOT POSSIBLE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE INITIAL EXAMINATION OF THE RETURNED EMBOTRAP DEVICE IDENTIFIED EVIDENCE OF DEFORMATION OF THE PROXIMAL SECTION OF THE DEVICE, AND ADVANCEMENT OF THE SHAFT WITHIN THE PROXIMAL JOINT. KINKING OF ONE OF THE PROXIMAL STRUTS OF THE OUTER CAGE WAS OBSERVED. THE PROXIMAL JOINT SHOWED EVIDENCE OF THE ADHESIVE PARTIALLY FAILING AND THE SHAFT MOVING WITHIN THE JOINT. THERE WAS EVIDENCE OF ADHESIVE PRESENT ON ALL COMPONENTS OF THE PROXIMAL JOINT INDICATING THAT A CORRECT ADHESIVE BOND WAS INITIALLY FORMED. THE OVERALL INTEGRITY OF THE PROXIMAL JOINT WAS MAINTAINED (I.E. THE STENT PORTION OF THE DEVICE AND THE SHAFT COMPONENT REMAINED JOINED TOGETHER). IT WAS ALSO OBSERVED THAT TWO OF THE FLOATING CROWNS IN ONE OF THE BODY SEGMENTS HAD BECOME INTERLOCKED. THIS WAS RESOLVED THROUGH GENTLE MANUAL MANIPULATION. NO FURTHER DAMAGE OR DEFORMATION OF THE DEVICE WAS NOTED. THE VISUAL INSPECTION ALSO INDICATES THAT THE RETURNED EMBOTRAP DEVICE WAS CORRECTLY ASSEMBLED AND MANUFACTURED, WITH ALL ADHESIVE BONDS AND JOINTS OTHER THAN THE PROXIMAL JOINT FULLY INTACT AND UNDAMAGED. THE DAMAGE PRESENT (DEFORMATION OF THE PROXIMAL STRUTS, ADVANCEMENT OF THE SHAFT WITHIN THE PROXIMAL JOINT, INTERLOCKING OF THE FLOATING CROWNS OF THE BODY SECTION) NOTED DURING THE VISUAL INSPECTION UNDER MAGNIFICATION IS CONSISTENT WITH ADVANCEMENT OF THE DEVICE AGAINST RESISTANCE. UNDER CERTAIN CONDITIONS ADVANCEMENT OF THE DEVICE AGAINST RESISTANCE CAN RESULT IN THE DAMAGE OBSERVED ON THE RETURNED DEVICE: DEFORMATION OF THE PROXIMAL STRUTS OF THE DEVICE CAN BE CAUSED WHERE THE PROXIMAL SECTION OF THE DEVICE ADVANCES WHILE THE BODY SECTIONS OR DISTAL SECTION OF THE DEVICE REMAIN IN PLACE DURING ATTEMPTED DELIVERY OF THE DEVICE. THIS COULD BE CAUSED BY A FAILURE TO CORRECTLY SEAT THE DEVICE IN THE MICROCATHETER HUB DURING DELIVERY INTO THE MICROCATHETER, OR IF THE DEVICE MEETS AN OBSTRUCTION WITHIN THE CATHETER BEING USED WHICH PREVENTS ADVANCEMENT DURING DELIVERY. ADVANCEMENT OF THE SHAFT WITHIN THE PROXIMAL JOINT CAN OCCUR WHEN THE FORCE APPLIED TO THE SHAFT DURING DELIVERY CAUSES THE ADHESIVE BOND ON THE SHAFT TO FAIL. THIS CAN BE CAUSED BY THE PROXIMAL SECTION OF THE DEVICE REMAINING IN PLACE WHILE THE SHAFT IS ATTEMPTED TO BE ADVANCED FORWARD, WITH THE ADHESIVE BOND FAILING EVENTUALLY AND THE SHAFT ADVANCING WITHIN THE PROXIMAL JOINT. THIS SCENARIO COULD ARISE ALSO FROM THE DEVICE NOT BEING SEATED CORRECTLY WITHIN THE MICROCATHETER HUB OR IF THE DEVICE MEETS AN OBSTRUCTION WITHIN THE CATHETER BEING USED WHICH PREVENTS ADVANCEMENT DURING DELIVERY. HOWEVER, THE DAMAGE NOTED TO THE DEVICE IS MINOR AND DOES NOT SUGGEST THE FORCES REQUIRED TO COMPROMISE THE ADHESIVE BOND WERE APPLIED TO THE DEVICE, THEREFORE IT IS MORE PROBABLE THAT THE ADHESIVE BOND WAS COMPROMISED DUE TO THE EXTENDED EXPOSURE OF THE ADHESIVE TO MOISTURE (POST-USE) DURING THE RETURN OF THE DEVICE TO CERENOVUS. INTERLOCKING OF THE FLOATING CROWNS OF THE BODY SECTIONS OUTER CAGE CAN OCCUR WHEN THE DEVICE IS IN AN EXPANDED STATE. IN AN EXPANDED STATE THE FLOATING CROWN CELLS OF THE DEVICE ARE OPEN, INCREASING THE POSSIBILITY OF INTERACTION BETWEEN ADJACENT FLOATING CROWNS. IF THE DEVICE IS ADVANCED IN AN EXPANDED STATE AND MEETS RESISTANCE, THIS CAN RESULT IN DEFORMATION OF THE BODY SECTIONS FROM THE INTENDED SHAPE AND CONFIGURATION, AND POTENTIALLY RESULT IN ONE FLOATING CROWN ENGAGING WITH THE OPENING OF AN ADJACENT FLOATING CROWN CELL AND BECOMING INTERLOCKED. ADVANCEMENT OF THE DEVICE IN AN EXPANDED STATE COULD RESULT IF THE DEVICE IS ADVANCED WITHIN A LUMEN LARGER THAN THE RECOMMENDED MICROCATHETER LUMEN SIZE RANGE (0.021 INCH ¿ 0.027 INCH). THE RETURNED EMBOTRAP DEVICE WAS SUCCESSFULLY PASSED THROUGH A 0.0195-INCH INNER DIAMETER (ID) TUBE, CONFIRMING THAT THE PROFILE CONFORMED TO THE SPECIFICATION FOR COMPATIBILITY WITH 0.021-INCH MICROCATHETERS. THE POLYTETRAFLUOROETHYLENE (PTFE) INSERTION TOOL WAS DIMENSIONALLY INSPECTED AND FOUND TO BE WITHIN SPECIFICATION FOR THE INNER AND OUTER DIAMETER. DEVICE INSERTION AND DELIVERY ASSESSMENTS WERE PERFORMED USING THE RETURNED EMBOTRAP DEVICE AND THE RETURNED HEADWAY 21 MICROCATHETER. THE RETURNED EMBOTRAP DEVICE WAS DELIVERED SUCCESSFULLY TO THE TIP OF THE RETURNED HEADWAY 21 MICROCATHETER, WITH NO ISSUES IN LOADING OF THE DEVICE INTO THE MICROCATHETER THROUGH THE MICROCATHETER HUB. THE COMPLAINT EVENT COULD NOT BE CONFIRMED USING THE RETURNED EMBOTRAP DEVICE AND RETURNED HEADWAY 21 MICROCATHETER. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (21F020AV) TOP AND SUB ASSEMBLY PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NON-CONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. INVESTIGATION CONCLUSION: THE RETURNED EMBOTRAP DEVICE EXHIBITS CHARACTERISTICS WHICH ARE CONSISTENT WITH ADVANCEMENT OF THE DEVICE AGAINST RESISTANCE. VISUAL INSPECTION OF THE DEVICE SHOWED EVIDENCE OF KINKING OF THE PROXIMAL SECTION OF THE DEVICE, ADVANCEMENT OF THE SHAFT WITHIN THE PROXIMAL JOINT AND INTERLOCKING OF THE FLOATING CROWNS ON ONE OF THE BODY SECTIONS. A VISUAL EXAMINATION OF THE MICROCATHETER USED DURING THE COMPLAINT EVENT INDICATED NO DAMAGE OR DEFORMATION PRESENT ON THE RETURNED MICROCATHETER. DELIVERY ASSESSMENTS CARRIED OUT WITH THE RETURNED EMBOTRAP DEVICE AND RETURNED HEADWAY 21 MICROCATHETER WERE CARRIED OUT, WITH THE RETURNED EMBOTRAP DEVICE DELIVERING SUCCESSFULLY WITH NO ISSUES TO THE TIP OF THE RETURNED HEADWAY 21 MICROCATHETER. THE COMPLAINT EVENT WAS NOT CONFIRMED USING THE RETURNED PRODUCTS. BASED ON THE INVESTIGATION CARRIED OUT, THE RETURNED EMBOTRAP SHOWS DAMAGE CONSISTENT WITH ADVANCEMENT AGAINST RESISTANCE. THE DAMAGE OBSERVED ON THE RETURNED DEVICE COULD HAVE BEEN CAUSED BY A CONDITION WHICH RESULTED IN RESISTANCE TO ADVANCEMENT. THE COMPLAINT EVENT WAS NOT RECREATED DURING DELIVERY ASSESSMENTS; THEREFORE THE ROOT CAUSE OF THE COMPLAINT EVENT CANNOT BE DETERMINED BUT IT CAN BE CONCLUDED THAT IT WAS NOT DUE TO A DEFECT WITH THE EMBOTRAP OR HEADWAY DEVICES. THE COMPLAINT REPORT STATED THAT THE RETURNED EMBOTRAP DEVICE AND HEADWAY 21 MICROCATHETER WERE USED SUCCESSFULLY FOR TWO PASSES, AND DURING THIS INVESTIGATION THE RETURNED PRODUCTS WERE ALSO USED SUCCESSFULLY. THEREFORE, THERE IS NO INDICATION THAT THIS COMPLAINT WAS AS A RESULT OF A DEFECT WITH THE EMBOTRAP DEVICE. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE TARGETING AN OCCLUSION IN THE MIDDLE CEREBRAL ARTERY (MCA), THE 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE (ET307537 / 21F020AV) WAS SUCCESSFULLY USED FOR THE FIRST PASS; IT WAS INITIALLY REPORTED THAT THE EMBOTRAP III DEVICE COULD NOT BE INTRODUCED INTO THE HEADWAY® 21 MICROCATHETER (MICROVENTION) FOR A SECOND PASSAGE. FURTHER INFORMATION RECEIVED INDICATED THAT THE TARGET OCCLUSION WAS TREATED WITH THE EMBOTRAP III DEVICE WITH TWO PASSES. THE HARD CLOT WAS RECANALIZED WITH A COMPETITOR PRODUCT RESULTING IN A MODIFIED TREATMENT IN CEREBRAL INFARCTION (MTICI) SCORE OF 3. THE INFORMATION INDICATED THAT THE EMBOTRAP III DEVICE WAS USED TWO (2) TIMES WITHOUT PROBLEMS. ON THE THIRD ATTEMPT, THE EMBOTRAP III WAS INSERTED INTO THE INSERTION TOOL AND IT WAS INTRODUCED INTO THE MICROCATHETER. ADVANCEMENT INTO THE MICROCATHETER WAS ONLY POSSIBLE FOR A VERY LIMITED PORTION; FURTHER ADVANCEMENT WAS NOT POSSIBLE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 25-FEB-2022, THE DEVICE CAGE ASSEMBLY WAS OBSERVED DEFORMED AND THE OUTER CAGE WAS KINKED. THE EVENT HAS BEEN DEEMED REPORTABLE AS A "MALFUNCTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2399767 EMBOTRAP III 5 MM X 37 MM CATHETER, THROMBUS RETRIEVER NRY NEURAVI LTD. 21F020AV

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HEADWAY® 21 MICROCATHETER (MICROVENTION)