BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSMOS 10 ADVANCED

    MDR report key: 19610784 · Received June 25, 2024

    Report

    Report Number
    2032493-2024-00491
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    June 5, 2024
    Report Date
    August 9, 2024
    Manufacturer
    MICROVENTION INC.
    Product Code
    KRD
    UDI-DI
    00842429105085
    PMA / PMN Number
    K102365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS STATED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RETURNED AND CLARIFICATION WAS REQUESTED. THE ALLEGED PRODUCT ISSUE AND EVENT AS DESCRIBED COULD NOT BE CONFIRMED. IF THE DEVICE IS RECEIVED AT A LATER DATE, AN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL MDR WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 0

    H11: INVESTIGATION FINDINGS ITEMS RETURNED FOR EVALUATION: -PUSHER -MICROCATHETER -UNKNOWN DEVICE ITEMS NOT RETURNED FOR EVALUATION: -IMPLANT -INTRODUCER -SHRINK LOCK -DISPENSER HOOP -V-GRIP THE PUSHER WAS RETURNED PARTIALLY WITHIN THE MICROCATHETER. THE IMPLANT WAS NOT ATTACHED TO THE PUSHER, BUT NO SIGNS OF ACTIVATION WAS OBSERVED ON THE PUSHER HEATER COIL. THE PUSHER BODYCOIL WAS FOUND STRETCHED AND ENTANGLED AT THE MIDDLE SECTION. THE IMPLANT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION OF THE PUSHER FOUND THE MONOFILAMENT BROKEN, WHICH INDICATES THAT THE DEVICE EXPERIENCED A TENSILE BREAK. AN UNKNOWN DEVICE WAS RETURNED WAS FOUND TO BE STRETCHED AND BROKEN. THE RETURNED MICROCATHETER WAS FOUND TO BE IN GOOD CONDITION WITH NO KINK/DAMAGE OBSERVED. 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): PLEASE REFER TO THE CHINESE 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: HEMATOMA AT THE SITE OF ENTRY, VESSEL PERFORATION, ANEURYSM RUPTURE, PARENT ARTERY OCCLUSION, INCOMPLETE ANEURYSM FILLING, EMBOLI, HEMORRHAGE, ISCHEMIA, VASOSPASM, COIL MIGRATION OR MISPLACEMENT, PREMATURE OR DIFFICULT COIL DETACHMENT, CLOT FORMATION, REVASCULARIZATION, POST-EMBOLIZATION SYNDROME, AND NEUROLOGICAL DEFICITS INCLUDING STROKE AND POSSIBLY DEATH. CASES OF CHEMICAL ASEPTIC MENINGITIS, EDEMA, HYDROCEPHALUS AND/OR HEADACHES HAVE BEEN ASSOCIATED WITH THE USE OF EMBOLIZATION COILS IN THE TREATMENT OF LARGE AND GIANT ANEURYSMS. THE PHYSICIAN SHOULD BE AWARE OF THESE COMPLICATIONS AND INSTRUCT PATIENTS WHEN INDICATED. APPROPRIATE PATIENT MANAGEMENT SHOULD BE CONSIDERED. WARNINGS AND PRECAUTIONS ¿ THE MCS IS INTENDED FOR SINGLE USE ONLY. DO NOT RESTERILIZE AND/OR REUSE THE DEVICE. AFTER USE, DISPOSE IN ACCORDANCE WITH HOSPITAL, ADMINISTRATIVE AND/OR LOCAL GOVERNMENT POLICY. DO NOT USE IF THE PACKAGING IS BREACHED OR DAMAGED. ¿ IF A COIL MUST BE RETRIEVED FROM THE VASCULATURE AFTER DETACHMENT, DO NOT ATTEMPT TO WITHDRAW THE COIL WITH A RETRIEVAL DEVICE, SUCH AS A SNARE, INTO THE DELIVERY CATHETER. THIS COULD DAMAGE THE COIL AND RESULT IN DEVICE SEPARATION. REMOVE THE COIL, MICROCATHETER, AND ANY RETRIEVAL DEVICE FROM THE VASCULATURE SIMULTANEOUSLY. DETACHMENT OF THE MCS COIL 32. WHEN THE V GRIP® DETACHMENT CONTROLLER IS PROPERLY CONNECTED TO THE V TRAK® DELIVERY PUSHER, A SINGLE AUDIBLE TONE WILL SOUND AND THE LIGHT WILL TURN GREEN TO SIGNAL THAT IT IS READY TO DETACH THE COIL. IF THE DETACHMENT BUTTON IS NOT PUSHED WITHIN 30 SECONDS, THE SOLID GREEN LIGHT WILL SLOWLY FLASH GREEN. BOTH FLASHING GREEN AND SOLID GREEN LIGHTS INDICATE THAT THE DEVICE IS READY TO DETACH. IF THE GREEN LIGHT DOES NOT APPEAR, CHECK TO ENSURE THAT THE CONNECTION HAS BEEN MADE. IF THE CONNECTION IS CORRECT AND NO GREEN LIGHT APPEARS, REPLACE THE V GRIP® DETACHMENT CONTROLLER. 34. PUSH THE DETACHMENT BUTTON. WHEN THE BUTTON IS PUSHED, AN AUDIBLE TONE WILL SOUND AND THE LIGHT WILL FLASH GREEN. 35. AT THE END OF THE DETACHMENT CYCLE, THREE AUDIBLE TONES WILL SOUND AND THE LIGHT WILL FLASH YELLOW THREE TIMES. THIS INDICATES THAT THE DETACHMENT CYCLE IS COMPLETE. IF THE COIL DOES NOT DETACH DURING THE DETACHMENT CYCLE, LEAVE THE V GRIP® DETACHMENT CONTROLLER ATTACHED TO THE V TRAK® DELIVERY PUSHER AND ATTEMPT ANOTHER DETACHMENT CYCLE WHEN THE LIGHT TURNS GREEN. 36. THE LIGHT WILL TURN RED AFTER THE NUMBER OF DETACHMENT CYCLES SPECIFIED ON THE V GRIP® LABELING. DO NOT USE THE V GRIP® DETACHMENT CONTROLLER IF THE LIGHT IS RED. DISCARD THE V GRIP® DETACHMENT CONTROLLER AND REPLACE IT WITH A NEW ONE WHEN THE LIGHT IS RED. 37. VERIFY DETACHMENT OF THE COIL BY FIRST LOOSENING THE RHV VALVE, THEN PULLING BACK SLOWLY ON THE DELIVERY SYSTEM AND VERIFYING THAT THERE IS NO COIL MOVEMENT. IF THE IMPLANT DID NOT DETACH, DO NOT ATTEMPT TO DETACH IT MORE THAN TWO ADDITIONAL TIMES. IF IT DOES NOT DETACH AFTER THE THIRD ATTEMPT, REMOVE THE DELIVERY SYSTEM. INVESTIGATION CONCLUSION THE INVESTIGATION FOUND THE PUSHER RETURNED WITHOUT THE IMPLANT ATTACHED, BUT NO INDICATIONS OF ACTIVATION USING A DETACHMENT CONTROLLER WAS OBSERVED ON THE PUSHER HEATER COIL. FURTHER INSPECTION FOUND THE PUSHER BODYCOIL TO BE STRETCHED AND ENTANGLED AT THE MIDDLE SECTION. THE IMPLANT WAS NOT RETURNED FOR EVALUATION. THE PUSHER'S MONOFILAMENT SHOWED A TENSILE BREAK SHAPE AT THE TIP, WHICH IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCE THAT EXCEEDED THE STRENGTH OF THE MONOFILAMENT CAUSING THE IMPLANT TO SEPARATE FROM THE PUSHER. HOWEVER, WITHOUT RADIOGRAPHIC IMAGING FROM THE PROCEDURE, THIS INVESTIGATION COULD NOT DETERMINE IF ANY PART OF THE COIL WAS PULLED OUT OF THE ANEURYSM AS DESCRIBED IN THE REPORTED EVENT. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE STRETCHED PUSHER, BUT THIS CONDITION IS CONSISTENT WITH THE DEVICE EXPERIENCING RETRACTION FORCES OVER SPECIFICATION.

    Description of Event or Problem · 0

    AS REPORTED: THE ANEURYSM WAS LOCATED AT M1 OF THE MIDDLE CEREBRAL ARTERY, WITH A SIZE OF 6.3 X 5.4. THE STENT MICROCATHETER AND COIL MICROCATHETER WERE IN PLACE, THE COIL 3X6 COSMOS WAS THE LAST COIL OF THE EMBOLIZATION PROCESS, AND THE COIL WAS TRANSPORTED TO THE END DUE TO THE HIGH PACKING DENSITY IN THE TUMOR. THE LEAD TO PUSH RESISTANCE WAS LARGE, REPEATED ADJUSTMENT OF THE POSITION WAS STILL NOT IDEAL AND THE SURGEON DECIDED TO DIRECTLY RELEASE. THE COIL WAS NOT COMPLETELY RELEASED. WHEN PULLING BACK THE PUSHER, THE END OF THE COIL WAS PULLED TO THE NEAR END AGAIN AND THE PHYSICIAN FOUND THAT HALF OF THE COIL WAS INSIDE THE ANEURYSM AND THE OTHER HALF WAS OUTSIDE THE ANEURYSM. AN INTRACRANIAL STENT WAS USED TO COMPRESS THE OVERFLOWING END OF COIL TO PREVENT THE COIL TO ESCAPE. IT IS NOTED THE DETACHMENT CONTROLLER (DC) WAS USED MANY TIMES BEFORE THIS PROCEDURE. AT PRESENT, THE PATIENT IS IN STABLE CONDITION AND HAS BEEN DISCHARGED FROM HOSPITAL WITHOUT ANY ADVERSE CONSEQUENCES. PLEASE NOTE THE PATIENT AND PHYSICIAN INFORMATION HAVE BEEN REDACTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED, PLEASE SEE D4, H6 & H11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480533 COSMOS 10 ADVANCED DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICROVENTION INC. 8210-0306-A1 0000439608 00842429105085

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention