BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB ANEURYSM EMBOLIZATION SYSTEM

    MDR report key: 20899020 · Received December 10, 2024

    Report

    Report Number
    2032493-2024-00894
    Event Type
    Injury
    Date Received
    December 10, 2024
    Date of Event
    November 19, 2024
    Report Date
    December 10, 2024
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OPR
    PMA / PMN Number
    P170032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION FINDINGS: ITEMS RETURNED: - N/A; DEVICE REMAINS IMPLANTED IN THE PATIENT. VISUAL ANALYSIS: A VISUAL INSPECTION OF THE DEVICE CAPTURED IN THIS FILE COULD NOT BE PERFORMED AS A PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION, NOR WERE ANY IMAGES OF THE DEVICE PROVIDED IN PLACE OF A DEVICE RETURN. PROCEDURE AND MEDICAL IMAGING WERE NOT PROVIDED FOR THIS INVESTIGATION. INVESTIGATION FINDINGS: WITHOUT THE RETURN AND PHYSICAL EVALUATION OF THE DEVICE, THE INVESTIGATION CANNOT FURTHER EXAMINE IF A CONDITION EXISTED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. WITHOUT IMAGING, THE INVESTIGATION CANNOT FURTHER VERIFY IF THE EVENT OCCURRED AS DESCRIBED, NOR COULD THE INVESTIGATION FURTHER EVALUATE THE CAUSE OF THE REPORTED EVENT. BASED ON A REVIEW OF THE DEVICE¿S RISK DOCUMENTATION, THE REPORTED EVENT DID NOT INDICATE THERE WERE THE PRESENCE OF ANY POTENTIAL OR NEW MANUFACTURING, DESIGN, QUALITY, OR OTHER SYSTEMIC ISSUES, OR NON-CONFORMANCES. THE COMPLAINT CODE IS MONITORED THROUGH THE TRENDING PROCESS; CORRECTIVE ACTION IS DETERMINED, AS NEEDED, THROUGH THIS PROCESS. INVESTIGATIONS OF HISTORIC COMPLAINT FILES WITH SIMILAR COMPLAINT CATEGORY CODING ARE RECORDED IN THE COMPLAINT HANDLING SYSTEM; WITHOUT THE ABILITY TO PERFORM AN ANALYSIS OF THE DEVICE, THIS INVESTIGATION CANNOT IDENTIFY WITH CERTAINTY ANY POTENTIAL ROOT CAUSES. BATCH REVIEW: A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART / LOT NUMBER COMBINATION COULD NOT BE PERFORMED AS THIS INFORMATION WAS NOT AVAILABLE AT THE TIME THIS INVESTIGATION WAS PERFORMED. COMPLAINT SYSTEM REVIEW: A SEARCH OF THE COMPLAINT HANDLING SYSTEM COULD NOT BE PERFORMED TO DETERMINE IF OTHER SIMILAR COMPLAINTS EXIST FOR THIS BATCH NUMBER, BECAUSE THE BATCH NUMBER WAS NOT PROVIDED FOR THE PRODUCT ON THIS COMPLAINT FILE. IFU REVIEW (ADDITIONAL INFORMATION CAN BE FOUND IN THE IFU): PLEASE REFER TO THE JAPANESE IFU FOR PRECAUTIONS, WARNINGS, AND FURTHER INFORMATION. THE FOLLOWING IS TAKEN FROM THE ENGLISH VERSION: POTENTIAL COMPLICATIONS POTENTIAL COMPLICATIONS INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING: HEMATOMA AT THE SITE OF ENTRY, ANEURYSM RUPTURE, EMBOLI, VESSEL PERFORATION, PARENT ARTERY OCCLUSION, HEMORRHAGE, ISCHEMIA, VASOSPASM, CLOT FORMATION, DEVICE MIGRATION OR MISPLACEMENT, PREMATURE OR DIFFICULT DEVICE DETACHMENT, NON-DETACHMENT, INCOMPLETE ANEURYSM FILLING, REVASCULARIZATION, POST-EMBOLIZATION SYNDROME, AND NEUROLOGICAL DEFICITS INCLUDING STROKE AND DEATH. WARNINGS AND PRECAUTIONS ¿ THE WEB ANEURYSM EMBOLIZATION SYSTEM IS INTENDED FOR SINGLE USE ONLY. THE DETACHMENT CONTROL DEVICE IS INTENDED TO BE USED FOR ONE PATIENT. DO NOT RE-STERILIZE AND/OR REUSE THE DEVICE. REUSE AND/OR RE-STERILIZATION CAN INCREASE RISK OF INFECTION, CAUSE A PYROGENIC RESPONSE OR OTHER LIFE-THREATENING COMPLICATIONS. REUSE AND/OR RE-STERILIZATION CAN DEGRADE PRODUCT PERFORMANCE, LEADING TO DEVICE MALFUNCTION. DISPOSE OF ALL DEVICES IN ACCORDANCE WITH APPLICABLE HOSPITAL, ADMINISTRATIVE AND/OR LOCAL GOVERNMENT POLICY. ¿ ADVANCE AND RETRACT THE DEVICE SLOWLY. DO NOT ADVANCE THE DELIVERY DEVICE WITH EXCESSIVE FORCE. DETERMINE THE CAUSE OF ANY UNUSUAL RESISTANCE. REMOVE THE DEVICE IF EXCESSIVE FRICTION IS NOTED AND CHECK FOR DAMAGE. ¿ DO NOT ROTATE THE DELIVERY DEVICE DURING OR AFTER DELIVERY OF THE EMBOLIZATION DEVICE. ROTATING THE DEVICE MAY RESULT IN DAMAGE OR PREMATURE DETACHMENT. ¿ THE EMBOLIZATION DEVICE CANNOT BE DETACHED WITH ANY OTHER POWER SOURCE OTHER THAN A MICROVENTION INC. DETACHMENT CONTROL DEVICE. ENSURE THAT AT LEAST TWO DETACHMENT CONTROL DEVICES ARE AVAILABLE BEFORE INITIATING AN EMBOLIZATION PROCEDURE. PROCEDURE DETACHMENT OF THE DEVICE 31. THE DETACHMENT CONTROL DEVICE IS PRE-LOADED WITH BATTERIES AND WILL ACTIVATE WHEN THE DELIVERY DEVICE IS PROPERLY CONNECTED. 32. VERIFY THAT THE RHV IS FIRMLY LOCKED AROUND THE DELIVERY DEVICE BEFORE ATTACHING THE DETACHMENT CONTROL DEVICE TO ENSURE THAT THE EMBOLIZATION DEVICE DOES NOT MOVE DURING THE CONNECTION PROCESS. 33. ENSURE THAT THE DELIVERY DEVICE GOLD CONNECTORS ARE CLEAN AND FREE FROM BLOOD OR CONTRAST. IF NECESSARY, WIPE THE CONNECTORS WITH STERILE WATER AND DRY BEFORE CONNECTING. 34. INSERT THE PROXIMAL END OF THE DELIVERY DEVICE INTO THE DETACHMENT CONTROL DEVICE. WHEN THE DELIVERY DEVICE IS PROPERLY CONNECTED, THE LIGHT WILL FLASH GREEN, AND AN INTERMITTENT TONE WILL BE HEARD. 35. VERIFY THE EMBOLIZATION DEVICE POSITION BEFORE PRESSING THE DETACHMENT BUTTON. 36. PUSH THE DETACHMENT BUTTON. DURING FIRING, THE LIGHT SHOULD BE SOLID GREEN, AND THE BEEP SHOULD BE CONTINUOUS. 37. VERIFY DETACHMENT BY FIRST LOOSENING THE RHV VALVE, THEN PULLING BACK SLOWLY ON THE DELIVERY DEVICE AND VERIFYING THAT THERE IS NOT EMBOLIZATION DEVICE MOVEMENT. IF THE EMBOLIZATION DEVICE DOES NOT DETACH, PUSH THE DETACHMENT BUTTON AGAIN. IF THE DEVICE IS STILL NOT DETACHED, OBTAIN A NEW DETACHMENT CONTROL DEVICE AND ATTEMPT DETACHMENT UP TO TWO ADDITIONAL TIMES. IF IT DOES NOT DETACH, REMOVE THE DELIVERY DEVICE. 38. VERIFY THE POSITION OF THE EMBOLIZATION DEVICE ANGIOGRAPHICALLY THROUGH THE GUIDE CATHETER. 39. PRIOR TO REMOVING THE MICROCATHETER FROM THE TREATMENT SITE, PLACE AN APPROPRIATELY SIZED GUIDEWIRE COMPLETELY THROUGH THE MICROCATHETER LUMEN TO ENSURE THAT NO PART OF THE EMBOLIZATION DEVICE REMAINS WITHIN THE MICROCATHETER. INVESTIGATION CONCLUSION: THE PHYSICAL DEVICE WAS NOT AVAILABLE FOR EVALUATION TO INVESTIGATE IF A CONDITION EXISTED THAT WOULD HAVE CONTRIBUTED TO EVENT. SUPPLEMENTAL IMAGING WAS ALSO UNAVAILABLE FOR REVIEW; WITHOUT IMAGING, THE INVESTIGATION CANNOT VERIFY THE EVENT OCCURRED AS DESCRIBED, NOR COULD THE INVESTIGATION FURTHER EXAMINE THE CAUSE OF THE REPORTED EVENT. THIS INFORMATION MAY BE UPDATED IF ADDITIONAL INFORMATION IS PROVIDED AT A LATER DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN 8-4 WEB EMBOLIZATION DEVICE WAS PLACED IN A BA TOP ANEURYSM (SIZE: 7MM). AFTER THE WEB DEVICE WAS PLACED AND DETACHED IN A BA TOP ANEURYSM, THE DEVICE WAS FOUND TO BE SLIGHTLY PROTRUDING INTO THE PARENT VESSEL DUE TO MIGRATION. A STENT WAS ADDITIONALLY IMPLANTED NEAR THE WEB DEVICE TO JACK UP THE EMBOLIZATION DEVICE INTO THE ANEURYSM, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO HEALTH DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2405303 WEB ANEURYSM EMBOLIZATION SYSTEM WEB 27 SL 8X4 OPR MICROVENTION, INC. MV-WB080427 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention 6FR SOFIA CATHETER| CHIKAI MICRO GUIDEWIRE| HEADWAY DUO, LOT# 0000598480| VIA 27 MICROCATHETER