BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLITAIRE FR

    MDR report key: 17245870 · Received July 3, 2023

    Report

    Report Number
    2029214-2023-01009
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    June 29, 2023
    Report Date
    September 29, 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

    PRODUCT ANALYSIS # (B)(4): ¿ AS FOUND CONDITION: THE SOLITAIRE FR REVASCULARIZATION DEVICE WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX, WITHIN AN OPENED SOLITAIRE FR INNER POUCH (B433554), AND WITHIN A DISPENSER COIL. THE SOLITAIRE FR REVASCULARIZATION DEVICE WAS RETURNED OUTSIDE 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'S NON-WORKING LENGTH WAS FOUND TO BE IN GOOD CONDITION. THE STENT DISTAL WORKING LENGTH STRUTS WERE FOUND ENTANGLED. THE REMAINING STENT WORKING LENGTH STRUTS WERE FOUND TO BE IN GOOD CONDITION. ¿ TESTING/ANALYSIS: NONE ¿ CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER'S "RESISTANCE DURING DELIVERY" AND "KINK/DAMAGE" REPORTS WERE CONFIRMED. DAMAGE TO THE SOLITAIRE FR REVASCULARIZATION STENT CAN OCCUR IF THE DEVICE IS ADVANCED AGAINST RESISTANCE. POSSIBLE CAUSES OF "RESISTANCE DURING DELIVERY" INCLUDE THE USE OF AN INCOMPATIBLE CATHETER, CATHETER DAMAGE, PATIENT VESSEL TORTUOSITY, OR THE USER DOES NOT MAINTAIN CONTINUOUS FLUSH. THE PATIENT'S VESSEL TORTUOSITY WAS "MODERATE", RULING OUT "VESSEL TORTUOSITY" AS A POTENTIAL CAUSE. INFORMATION REGARDING WHETHER A CONTINUOUS FLUSH WAS USED WAS NOT PROVIDED; THEREFORE, "USER DOES NOT MAINTAIN 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 "CATHETER DAMAGE" COULD NOT BE RULED OUT AS A POTENTIAL CAUSE. 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. IN THIS EVENT, IT IS LIKELY THE USE OF AN INCOMPATIBLE CATHETER 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 105-5081-153; THE COUNTRY OF THE EVENT IS CN 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

    HOLD NW. MEDTRONIC RECEIVED A REPORT THAT THE MICROCATHETER WAS IN PLACE, THE STENT SUPPORTED THE Y VALVE, AND THE HYDRATION WAS COMPLETED WITH CLEAN WATER, BUT IT COULD NOT BE PUSHED INTO THE MICROCATHETER. WHEN TAKEN OUT, THE TIP END OF THE STENT WAS BENT AND OVERLAPPED. IT WAS NOTED THAT POOR STENT VISUALIZATION OCCURRED. DSA WAS USED DURING THE PROCEDURE. THE STENT WAS NOT POSITIONED IN A BEND. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE 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 OF THE MIDDLE CEREBRAL ARTERY. THE MRS BASELINE WAS 0 AND PROCEDURE WAS 0. THE NIHSS BASELINE WAS 23 AND TICI WAS 0. THE NIHSS POST PROCEDURE WAS 15 AND TICI WAS 3. IV TPA WAS NOT CONTRAINDICATED. THERE WAS 0 PASSES WITH THE DEVICE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. STROKE ONSET TO REPERFUSION TIME WAS 4 HOURS. ANCILLARY DEVICES INCLUDE A REBAR 18 MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344203 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 SFR-6-30 B433554

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SEE H10...