BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB SL

    MDR report key: 20984589 · Received December 19, 2024

    Report

    Report Number
    2032493-2024-00929
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    December 6, 2024
    Report Date
    February 6, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OPR
    PMA / PMN Number
    P170032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PROCEDURE/MEDICAL INFORMATION REVIEW: IMAGING REVIEW, (B)(6), MVI, INC., MD, 2/1/2025: TWO RADIOGRAPHIC IMAGES WERE PROVIDED FOR REVIEW. THEY ARE NOT LABELED AS TO TIME OR DATE. THE REVIEW OF THE IMAGES IS AS FOLLOWS: THUMBNAIL_IMAGE002: RIGHT ICA AP SUBTRACTED DSA WITH CONTRAST, ARTERIAL PHASE. THERE IS A PCOM ANEURYSM THAT MEASURES ABOUT 5X7 MM. A WEB IS INSIDE THE ANEURYSM AND IT APPEARS APPROPRIATELY SIZED. THE WEB IS NOT DETACHED AND THE VIA CATHETER TIP IS JUST PROXIMAL TO THE BASE MARKER OF THE WEB. THUMBNAIL_IMAGE003: LATERAL SKULL SINGLE SHOT UNSUBTRACTED RADIOGRAPH, WITHOUT CONTRAST. THE WEB IS IN THE ANEURYSM. AN LVIS STENT HAS BEEN DEPLOYED FROM THE SUPRACLINOID ICA DISTAL TO THE ANEURYSM, BACK TO THE POSTERIOR ICA SIPHON. WALL APPOSITION OF THE EVO CANNOT BE EVALUATED SINCE NO CONTRAST HAS BEEN INJECTED AND THERE IS ONLY ONE PROJECTION. THESE IMAGES DO NOT EXPLAIN WHY IT WAS DIFFICULT TO DETACH THE WEB. 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. 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. 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. 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 DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. COMPLAINT SYSTEM REVIEW: THERE ARE NO SIMILAR COMPLAINTS BASED ON THE COMPLAINT CATEGORY REGARDING THIS BATCH NUMBER FROM THE LAST TWO YEARS RECORDED IN THE COMPLAINT SYSTEM AT THE TIME OF THIS INVESTIGATION. IFU REVIEW (ADDITIONAL INFORMATION CAN BE FOUND IN THE IFU): 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 RESTERILIZE AND/OR REUSE THE DEVICE. REUSE AND/OR RESTERILIZATION CAN INCREASE RISK OF INFECTION, CAUSE A PYROGENIC RESPONSE OR OTHER LIFE THREATENING COMPLICATIONS. REUSE AND/OR RESTERILIZATION 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.

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THE REPORTED PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL SUBMIT A SUPPLEMENTAL MDR REPORT. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES DIFFICULT OR DELAYED DETACHMENT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, THE PHYSICIAN DEPLOYED A WEB IN ANEURYSM OF CAROTID ARTERY. WEB WAS PERFECTLY IMPLANTED. WHEN SHE DECIDED TO DETACH IT, IT WAS IMPOSSIBLE. SEVERAL WDC2 CONTROLLERS WERE USED, BUT NO DETACHMENT. IT WAS ATTEMPTED TO RETRIEVED IT. DURING WITHDRAWAL, THE WEB DETACHED INTO CAROTID ARTERY. IT WAS DECIDED TO PUSH IT INSIDE ANEURYSM AND NEEDED TO PUT A STENT (LVIS EVO) IN FRONT OF NECK OF ANEURYSM. THE PATIENT IS REPORTED WELL AND AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142413 WEB SL INTRASACCULAR FLOW DISRUPTION DEVICE OPR MICROVENTION, INC. W5-6-2-MVI-MDR 0000614961

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention