BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLITAIRE FR4

    MDR report key: 11149952 · Received January 11, 2021

    Report

    Report Number
    2029214-2021-00036
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Date of Event
    January 1, 2021
    Report Date
    April 9, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    PMA / PMN Number
    K183022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    PRODUCT ANALYSIS FINDINGS: THE SOLITAIRE X REVASCULARIZATION DEVICE (MODEL: SFR4-4-40-10 LOT: B013820), MICROCATHETER AND NON-MEDTRONIC CATHETER WERE RETURNED FOR ANALYSIS. THE SOLITAIRE X REVASCULARIZATION DEVICE WAS FOUND WITHIN THE MICROCATHETER. THE SOLITAIRE X PUSHER WAS REMOVED PROXIMALLY WITH NO RESISTANCE ENCOUNTERED. THE ALREADY SEPARATED SOLITAIRE X STENT WAS REMOVED DISTALLY. THE INNER DIAMETER (ID) OF THE MICRO CATHETER WAS MEASURED USING A PIN GAUGE SET AND FOUND TO BE 0.021¿ AT THE PROXIMAL END, WHICH IS WITHIN SPECIFICATION. THE DISTAL ID COULD NOT BE MEASURED DUE TO THE FLATTENING. THE REBAR-18 MICRO CATHETER IS COMPATIBLE FOR USE WITH THE SOLITAIRE X REVASCULARIZATION DEVICE PER INSTRUCTIONS FOR USE (IFU). AN IN-HOUSE MANDREL WAS INSERTED INTO THE CATHETER AND RESISTANCE WAS FELT AT ~5.0CM FROM THE PROXIMAL END. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE SOLITAIRE X PUSHER AND THE PTFE SHRINK TUBING WAS FOUND UNDAMAGED. NO BENDS OR KINKS WERE FOUND WITH THE SOLITAIRE X MARKER COIL. NO IRREGULARITIES WERE FOUND WITH THE SOLITAIRE X PROXIMAL MARKER/ATTACHMENT ZONE. THE SOLITAIRE X STENT NON-WORKING (TEAR DROP) LENGTH STRUTS WERE FOUND BROKEN NEAR THE ATTACHMENT ZONE. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE WORKING LENGTH STRUTS OR FINGER MARKERS. THE SOLITAIRE X STENT WAS SENT OUT FOR SEM (SCANNING ELECTRON MICROSCOPY) ANALYSIS FOR FAILURE ANALYSIS OF THE BROKEN STRUTS. PER THE SEM ANALYSIS REPORT, THE STRUT BROKEN END "BREAK1" WIDTH WAS MEASURED TO BE 35.03¿M BY 76.96¿M, THE UNDAMAGED SECTION WIDTH WAS MEASURED TO BE 125.77¿M BY 61.03¿M, WHICH IS WITHIN SPECIFICATION. THE STRUT BROKEN END ¿BREAK2¿ WIDTH WAS MEASURED TO BE 34.30¿M BY 62.83¿M, THE UNDAMAGED SECTION WIDTH WAS MEASURED TO BE 60.74¿M BY 128.05¿M, WHICH IS WITHIN SPECIFICATION. THE SOLITAIRE X COULD NOT BE USED FOR RESISTANCE TESTING DUE TO THE DAMAGED STATE. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿CATHETER RESISTANCE¿ WAS CONFIRMED, HOWEVER THE CUSTOMER REPORT OF ¿RESISTANCE DURING DELIV/RETRIEVAL¿ COULD NOT BE CONFIRMED. IN-HOUSE RESISTANCE TESTING OF THE REBAR-18 FOUND RESISTANCE NEAR THE DAMAGED CATHETER SECTION. OTHER POSSIBLE CAUSES OF RESISTANCE ARE PATIENT VESSEL TORTUOSITY, USER DOES NOT MAINTAIN CONTINUOUS FLUSH, RHV LOOSE DURING DELIVERY, DEVICE RETRACTED ABRUPTLY OR INTRODUCER SHE ATH DAMAGE. CUSTOMER REPORTED DEVICES WERE PREPARED PER IFU. THE CUSTOMER REPORT OF ¿PUSHWIRE BREAK/SEPARATION¿ WAS NOT CONFIRMED, HOWEVER, THE STENT WAS CONFIRMED TO BE BROKEN AND LIKELY THE BREAK REFERENCED BY CUSTOMER. THE DAMAGE TO THE STENT IS CONSISTENT WITH POSSIBLE DAMAGE CAUSED BY RESISTANCE. SEM SUMMARY: ¿BREAK 1: A SMALL AREA OF FATIGUE CRACKING INITIATED FROM THE WIRE SURFACE IS VISIBLE. THE REST OF THE FRACTURE FAILED VIA TENSION OVERLOAD. BREAK 2: DIMPLE FEATURES CONSISTENT WITH TENSILE OVERLOAD FEATURES ARE VISIBLE ON THE FRACTURE SURFACE.¿ HOWEVER, THE ROOT CAUSE FOR THE DAMAGES COULD NOT BE DETERMINED. THERE IS NO INDICATION THAT THE EVENT IS RELATED TO A POTENTIAL MANUFACTURING ISSUE. 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CLOT WAS CAUGHT. THE SOLITAIRE X BASKED WAS 80-90% IN THE REBAR CATHETER SO THE CLOT COULD BE WITHDRAWN WITH REBAR, AND WAS RECOVERED SUCCESSFUL. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE PUSHWIRE BROKE AFTER THE DEVICE COULDN¿T BE WITHDRAWN THROUGH THE REBAR 18 CATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR A THROMBECTOMY TO REMOVE A CLOT LOCATED IN THE M2 SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY. IT WAS REPORTED THAT AFTER CATCHING THE CLOT, IT WASN¿T POSSIBLE TO WITHDRAW THE STENT COMPLETELY INTO THE CATHETER. AFTER A FEW ATTEMPTS THE PUSHER WIRE TORE OFF BELOW THE "BASKET". THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THE CLOT WAS REMOVED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45325 SOLITAIRE FR4 CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 SFR4-4-40-10 B013820

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR