BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLITAIRE AB STENT

    MDR report key: 13981721 · Received April 1, 2022

    Report

    Report Number
    2029214-2022-00557
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    December 13, 2021
    Report Date
    April 1, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: ¿ AS FOUND CONDITION: THE SOLITAIRE AB STENT DEVICE WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX, WITHIN A PLASTIC BIO-POUCH, WITHIN AN OPENED SOLITAIRE AB INNER POUCH (B230364), AND WITHIN A DISPENSER COIL. ¿ VISUAL INSPECTION/DAMAGE LOCATION DETAILS: THE SOLITAIRE AB STENT DEVICE WAS RETURNED WITHIN ITS INTRODUCER SHEATH. HOWEVER, THE I NTRODUCER SHEATH WAS RETURNED SEPARATED (CUT) INTO TWO SEGMENTS. THE FINGER MARKERS WERE EXAMINED WITHIN THE INTRODUCER SHEATH AND WERE FOUND TO BE ALIGNED PROPERLY. THE SOLITAIRE AB STENT DEVICE COULD NOT BE PUSHED OUT FROM WITHIN THE INTRODUCER SHEATH AS RESISTANCE WAS ENCOUNTERED; THEREFORE, THE DEVICE WAS PULLED OUT PROXIMALLY. THE SOLITAIRE AB MARKER COIL WAS FOUND BENT. VISUAL INSPECTION OF THE DETACHMENT ZONE REVEALED NO IRREGULARITIES OR ELECTRICAL ETCHING. THE STENT WAS FOUND TO BE STILL ATTACHED TO THE PUSHWIRE. THE STENT NON-WORKING (TEAR DROP) STRUTS WERE FOUND BENT WITH A BROKEN STRUT. THE STENT WORKING LENGTH STRUTS WERE IN GOOD CONDITION. ¿ TESTING/ANALYSIS: CONTINUITY TESTING WAS PERFORMED ON THE STENT DEVICE. THE STENT WAS ELECTRICALLY ISOLATED; THE DETACH WIRE WAS NOT ELECTRICALLY ISOLATED WHICH IS NORMAL. THESE RESULTS INDICATE THAT THE STENT SHOULD BE ABLE TO DETACH NORMALLY. THE DETACHMENT TEST WAS THEN PERFORMED USING AN IN-HOUSE SOLITAIRE CABLE SET (MODEL/LOT: NOT AVAILABLE) AND SOLITAIRE DETACHMENT BOX (MODEL: NDS-2X SERIAL: (B)(4)). THE STENT DETACHMENT OCCURRED AT 1 MINUTE 05 SECONDS. THE SOLITAIRE AB STENT WAS SENT OUT FOR SEM (SCANNING ELECTRON MICROSCOPY) ANALYSIS FOR FAILURE ANALYSIS OF THE BROKEN STRUT. PER THE ANALYSIS REPORT, ¿THE FRACTURE INITIATED FROM THE SURFACE VIA FATIGUE. THE REST OF THE SURFACE FAILED VIA OVERLOAD. MULTIPLE SECONDARY CRACKS ARE VISIBLE ON THE SURFACE.¿ THIS LIKELY INDICATES THE STRUT BECAME BENT BEFORE BREAKING. ¿ CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿NON-DETACHMENT¿ WAS CONFIRMED AS THE STENT WAS FOUND STILL ATTACHED TO THE PUSHER. THE INVESTIGATION DETERMINED THAT THIS EVENT WAS SIMILAR TO AN EVENT THAT HAD ALREADY BEEN INVESTIGATED, AND ANOTHER INVESTIGATION IS NOT NECESSARY. BASED ON THE FORMAL INVESTIGATION, USER ERRORS SUCH AS CONNECTING THE CABLES INCORRECTLY, NOT USING A NEW BATTERY, PLACING THE NEEDLE IN FAT CELLS, NOT EXPOSING THE DETACHMENT ZONE TO BLOOD FLOW OR PULLING THE MICROCATHETER BACK TOO FAR, AND NOT MAINTAINING SALINE DRIP THROUGH MICROCATHETER COULD CONTRIBUTE TO THE EVENT. ADDITIONALLY, IF NOT ENOUGH BLOOD THINNER IS USED, CLOTS CAN FORM ON THE DETACHMENT ZONE. THESE USER ERRORS CAN HAPPEN EVEN IF THE DEVICE IS WORKING CORRECTLY. HOWEVER, THE CAUSE FOR THE EVENT COULD NOT BE DETERMINED AS INSUFFICIENT INFORMATION WAS PROVIDED. REGARDING THE CUSTOMER¿S ¿KINK/DAMAGED¿ REPORT, THE ISSUE WAS CONFIRMED. FROM THE DAMAGES FOUND WITH THE RETURNED SOLITAIRE AB STENT DEVICE (MARKER COIL BENT, STENT BROKEN/BENT) IT APPEARS EXCESSIVE FORCE (PUSHING/PULLING) WAS USED. THE INVESTIGATION DETERMINED THAT THIS EVENT WAS SIMILAR TO AN EVENT THAT HAD ALREADY BEEN INVESTIGATED, AND ANOTHER INVESTIGATION IS NOT NECESSARY. PRODUCT LABELING WAS REVIEWED AND PROVIDES SEVERAL CONTRAINDICATIONS, COMPLICATIONS, WARNINGS, AND INSTRUCTIONS FOR THE USE AND HANDLING OF THE DEVICE IN ORDER TO PREVENT DAMAGE AND SEPARATION. BASED ON THE FORMAL INVESTIGATION CONDUCTED, DEVICE SEPARATION CAN OCCUR DUE TO ANATOMICAL CONSIDERATIONS SUCH AS LEVEL OF TORTUOSITY OR VARIANTS OF ANATOMY AT THE AORTIC ARCH OR NEUROVASCULATURE, DELIVERY AND RETRIEVAL FRICTION, RESISTANCE WHERE THE FORCES APPLIED TO THE BINDING OF THE SOLITAIRE DEVICE MAY BE GREATER, HIGHER NUMBER OF DEVICE PASSES, GUIDE CATHETER TECHNIQUE, GUIDE / BALLOON CATHETERS OR INTERMEDIATE CATHETER INTEGRITY ISSUES SUCH AS KINKING WITHIN THE SHAFT, PRESENCE OF A PRE-EXISTING EXTRA/INTRACRANIAL STENOSIS OR CALCIFIED PLAQUE, PRESENCE OF HARD CLOTS / THROMBUS ENTANGLEMENT WITH OVERBENDING DURING THE RETRACTION PROCESS, ALIGNMENT OF THE MICROCATHETER WITH THE PROXIMAL END OF THE SOLITAIRE DEVICE, REMOVAL OF THE MICROCATHETER PRIOR TO RETRIEVAL OF THE SOLITAIRE DEVICE WITH OR WITHOUT CLOT. HOWEVER, THE CAUSE FOR THE DAMAGES COULD NOT BE DETERMINED AS INSUFFICIENT INFORMATION WAS PROVIDED. 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 INFORMATION THAT SOLITAIRE STENT WAS UNABLE TO DETACH AND THE TIP WAS FOUND TO BE KINKED AFTER TAKING IT OUT. STROKE ONSET TO REPERFUSION TIME: 4H. THE DEVICES WERE PREPARED AS INDICATED AS IN THE INSTRUCTIONS FOR USE (IFU). NO SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1839174 SOLITAIRE AB STENT INTRACRANIAL NEUROVASCULAR STENT NJE MICRO THERAPEUTICS, INC. DBA EV3 SAB-6-30 B230364

    Patients

    Seq Age Sex Outcome Treatment
    1 Female