BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLITAIRE FR

    MDR report key: 17695408 · Received September 6, 2023

    Report

    Report Number
    2029214-2023-01603
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    September 4, 2023
    Report Date
    December 6, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS ¿ AS FOUND CONDITION: THE SOLITAIRE FR REVASCULARIZATION DEVICE WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX, A PLASTIC BIO-POUCH, AND WITHIN ITS INTRODUCER SHEATH. ¿ DAMAGE LOCATION DETAILS: NO BENDS OR KINKS WERE FOUND WITH THE SOLITAIRE FR PUSHER OR MARKER COIL. THE STENT WAS FOUND STILL ATTACHED TO THE PUSHER. THE STENT NON-WORKING (TEARDROP) LENGTH STRUTS WERE FOUND DAMAGED (BENT). THE STENT'S WORKING LENGTH STRUTS WERE FOUND TO BE IN GOOD CONDITION. ¿ TESTING/ANALYSIS: THE SOLITAIRE FR REVASCULARIZATION DEVICE WAS PUSHED OUT FROM WITHIN ITS INTRODUCER SHEATH WITHOUT ISSUE. ¿ CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER'S "RESISTANCE DURING DELIVERY" AND "KINK/DAMAGED" REPORTS WERE CONFIRMED. THE SOLITAIRE FR STENT CAN BECOME DAMAGED IF ADVANCED AGAINST RESISTANCE. POSSIBLE CAUSES OF "RESISTANCE DURING DELIVERY" INCLUDE USING AN INCOMPATIBLE CATHETER, CATHETER DAMAGE, PATIENT VESSEL TORTUOSITY, OR THE USER NOT MAINTAINING CONTINUOUS FLUSH. THE PATIENT'S VESSEL TORTUOSITY WAS "MINIMAL", RULING OUT PATIENT VESSEL TORTUOSITY AS A POTENTIAL CAUSE. INFORMATION REGARDING WHETHER A CONTINUOUS FLUSH WAS USED WAS NOT REPORTED; THEREFORE, FAILURE TO MAINTAIN A CONTINUOUS FLUSH COULD NOT BE RULED OUT AS A POTENTIAL CAUSE. THE REBAR-18 CATHETER USED IN THE EVENT WAS NOT RETURNED. THEREFORE, AN ANALYSIS COULD NOT BE PERFORMED, AND ANY CONTRIBUTING FACTORS (I.E., CATHETER DAMAGE) COULD NOT BE ASSESSED. THE REBAR-18 CATHETER HAS A LABELED INNER DIAMETER (ID) OF 0.021". AS 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, IN THIS EVENT, THE USE OF AN INCOMPATIBLE CATHETER LIKELY CONTRIBUTED TO THE REPORTED RESISTANCE. 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.

    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 IN THE EMERGENCY INTRACRANIAL ARTERY THROMBECTOMY, AFTER NORMAL HYDRATION AND EXHAUST, THE REBAR18 MICROCATHETER WAS PUSHED IN. DURING THE PUSHING PROCESS, THERE WAS OBVIOUS RESISTANCE, AND THE REBAR18 COULD NOT BE PUSHED OUT. AFTER TAKING IT OUT, IT WAS FOUND THAT THE DEPLOYMENT POINT OF THE SOLITAIRE WAS KINKED AND COULD NOT BE USED NORMALLY. AFTER REPLACING THE SOLITAIRE WITH THE SAME MODEL, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE RESISTANCE OCCURRED DURING PREP AND OCCURRED IN THE MIDDLE PART OF THE REBAR18. THE SOLITAIRE WAS NOT ABLE TO BE PUSHED OUT OF THE SHEATH AND THE SHEATH WAS NOT DAMAGED. THE SOLITAIRE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.   THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ISCHEMIC STROKE AT THE END OF THE INTERNAL CAROTID ARTERY (ICA). THE PATIENT'S MODIFIED RANKIN SCALE (MRS) SCORE WAS 5 DURING THE PROCEDURE AND 5 FOR A BASELINE. THE PATIENT'S NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE WAS 18 POST PROCEDURE AND FOR A BASELINE. THE PATIENT'S TICI SCORE WAS 17 FOR A BASELINE AND 17 POST PROCEDURE. IV TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT CONTRAINDICATED. ONLY 1 PASS WITH THE DEVICE WAS MADE. THE STROKE ONSET TO REPERFUSION TIME WAS 5 HOURS.  IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170798 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 SFR-6-30 B391132

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female