BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE FR

    MDR report key: 17599346 · Received August 22, 2023

    Report

    Report Number
    2029214-2023-01454
    Event Type
    Injury
    Date Received
    August 22, 2023
    Date of Event
    August 20, 2023
    Report Date
    December 6, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS#: (B)(4): EQUIPMENT USED: VIS (M-81805); DRAWING(S) REFERENCED: NONE AS FOUND CONDITION: THE SOLITAIRE FR PUSHER WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX, A PLASTIC BIO-POUCH, AND A DISPENSER COIL. DAMAGE LOCATION DETAILS: NO BENDS OR KINKS WERE FOUND WITH THE SOLITAIRE FR PUSHER. THE STENT WAS FOUND TO BE NOT ATTACHED TO THE PUSHER. THE STENT WAS NOT RETURNED AS IT REMAINS WITHIN THE PATIENT. THE SHRINK TUBING WAS REMOVED, AND THE MARKER COIL OUTER COILS WERE STRETCHED. THE PUSHER INNER CORE WIRE WAS FOUND BROKEN AT THE BUFFER COIL WELD. TESTING/ANALYSIS: NONE CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S ¿RESISTANCE DURING DELIVERY¿ AND ¿SEPARATION¿ REPORTS WERE CONFIRMED. POSSIBLE CAUSES OF ¿RESISTANCE DURING DELIVERY¿ INCLUDE USING AN INCOMPATIBLE CATHETER, CATHETER DAMAGE, PATIENT VESSEL TORTUOSITY, OR THE USER NOT MAINTAINING CONTINUOUS FLUSHING. POSSIBLE CAUSE OF ¿SEPARATION¿ INCLUDES PRESENCE OF A PRE-EXISTING EXTRA/INTRACRANIAL STENOSIS OR CALCIFIED PLAQUE, PATIENT VESSEL TORTUOSITY, HIGHER NUMBER OF DEVICE PASS, DELIVERY AND RETRIEVAL FRICTION, PRESENCE OF HARD CLOTS/THROMBUS ENTANGLEMENT WITH OVERBENDING DURING THE RETRACTION PROCESS, NOT ALIGNING THE MICROCATHETER WITH THE PROXIMAL END OF THE SOLITAIRE DEVICE, OR REMOVAL OF THE MICROCATHETER BEFORE RETRIEVAL OF THE SOLITAIRE DEVICE WITH OR WITHOUT CLOT. THE REBAR-18 CATHETER USED IN THE EVENT WAS NOT RETURNED. THEREFORE, AN ANALYSIS COULD NOT BE PERFORMED, AND ¿CATHETER DAMAGE¿ COULD NOT BE RULED OUT AS A POTENTIAL CAUSE. THE REBAR-18 CATHETER HAS A LABELED INNER DIAMETER (ID) OF 0.021¿. PER THE SOLITAIRE FR INSTRUCTIONS FOR USE (IFU), ¿SOLITAIRE¿ FR REVASCULARIZATION DEVICE WITH THE SFR-6-20 AND SFR-6-30 REFERENCE NUMBERS SHOULD BE INTRODUCED ONLY THROUGH A MICROCATHETER WITH A MINIMUM INSIDE DIAMETER OF 0.027 INCHES.¿ THEREFORE, THE REBAR-18 CATHETER WAS FOUND TO BE INCOMPATIBLE WITH THE SOLITAIRE FR REVASCULARIZATION DEVICE. THE PATIENT¿S VESSEL TORTUOSITY WAS ¿MODERATE¿; THEREFORE, IT IS UNLIKELY ¿PATIENT VESSEL TORTUOSITY¿ CONTRIBUTED TO THE REPORTED EVENT(S). INFORMATION REGARDING WHETHER A CONTINUOUS FLUSH WAS USED, IF THERE WAS ANY PRE-EXISTING EXTRA/INTRACRANIAL STENOSIS OR CALCIFIED PLAQUE, THE NUMBER OF DEVICE PASSES, PRESENCE OF HARD CLOTS/THROMBUS ENTANGLEMENT, OR ALIGNMENT OF THE CATHETER WITH THE PROXIMAL END OF THE SOLITAIRE DEVICE WAS NOT REPORTED; THEREFORE, COULD NOT BE RULED OUT AS POTENTIAL CAUSES. IN THIS EVENT, THE USE OF AN INCOMPATIBLE CATHETER LIKELY CONTRIBUTED TO THE REPORTED RESISTANCE ISSUE, SUBSEQUENTLY CAUSING THE DEVICE TO BECOME SEPARATED. HOWEVER, THE CAUSE OF THE DEVICE SEPARATION COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT THE END OF THE INTERNAL CAROTID ARTERY WAS OCCLUDED, AND THE SURGEON USED THE INTERMEDIATE CATHETER TO GO UP AND PERFORMED ASPIRATION AND THROMBECTOMY. AFTER ASPIRATION, THE THROMBUS ESCAPED TO THE MIDDLE CEREBRAL ARTERY M1 AND WAS RESCUED WITH SOLITAIRE6-30. AFTER THE STENT WAS ANCHORED AT THE M1 THROMBUS, THE SWIM TECHNIQUE WAS PREPARED TO REMOVE THE THROMBUS. DURING THE PROCESS OF THE INTERMEDIATE CATHETER BEING PUSHED TO GO UPPER, THE DETACHMENT POINT OF THE STENT WAS SUDDENLY DISCONNECTED. SINCE THE BLOOD VESSEL BARELY MAINTAINED THE BLOOD FLOW AFTER THE DETACHMENT, AND A REASONABLE WAY TO REMOVE THE STENT COULD NOT BE FOUND, THE STENT COULD ONLY BE LEFT IN THE PATIENT'S MIDDLE ARTERY M1. THE PATIENT'S THROMBUS WAS NOT WELL OPENED BECAUSE THE STENT WAS DETACHED IN M1 SEGMENT OF MIDDLE CEREBRAL ARTERY, AND THE CURRENT SITUATION NEEDS TO BE OBSERVED. THERE WAS RESISTANCE DURING THE DELIVERY PORTION OF THE PROCEDURE. THE VESSEL WAS MODERATELY TORTUOUS. IT FELT ASTRINGENT WHEN SOILITAIREFR PASSED REBAR 18, BUT IT COULD PASS. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE STROKE ONSET TO REPERFUSION TIME WAS 82 MINUTES. ANCILLARY DEVICES INCLUDE A VISTA BRITE TIP GUIDLING ACTHETER 588842P, SYNCHRO M00326410 GUIDEWIRE, SYNCHRO M00326410 GUIDEWIRE, AND DISTAL ACCESS CATHETER HEARTCARE DAC-6S125.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51584 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 SFR-6-30 B273990

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other