BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE FR4

    MDR report key: 20169885 · Received September 9, 2024

    Report

    Report Number
    2029214-2024-01536
    Event Type
    Death
    Date Received
    September 9, 2024
    Date of Event
    August 30, 2024
    Report Date
    November 14, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS # (B)(4), EQUIPMENT USED: VIS (M-78210), AS FOUND CONDITION: THE SOLITAIRE X REVASCULARIZATION DEVICE WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX AND A SEALED POUCH. DAMAGE LOCATION DETAILS: NO BENDS OR KINKS WERE FOUND WITH THE SOLITAIRE X PUSHER. THE STENT WAS FOUND STILL ATTACHED TO THE PUSHER. THE STENT¿S NON-WORKING LENGTH TEAR DROP STRUTS WERE FOUND BENT AND BROKEN. THE STENT¿S REMAINING WORKING LENGTH STRUTS WERE FOUND TO BE IN GOOD CONDITION. TESTING/ANALYSIS: THE BROKEN SOLITAIRE X STENT WAS SENT OUT SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS. PER THE SEM REPORT, THE BROKEN END FAILED VIA FATIGUE AND THEN OVERLOADED. CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S ¿TEARDROP STRUT DAMAGE/BROKEN¿ REPORT WAS CONFIRMED. THE RETURNED SOLITAIRE AB STENT WAS FOUND BENT AND BROKEN. DAMAGE TO THE SOLITAIRE AB STENT DEVICE CAN OCCUR IF ADVANCED/RETRIEVED AGAINST RESISTANCE. THE SEM ANALYSIS INDICATED THAT THE STENT BROKE DUE TO FATIGUE (BENDING) AND SUBSEQUENTLY BREAKING IF FORCE IS USED. HOWEVER, THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. DATE OF DEATH WAS GIVEN AS (B)(6) 2024 (MONTH AND YEAR VALID). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED THAT AN AUTOPSY IS BEING PERFORMED. THE AUTOPSY WASN'T PERFORMED IN THE HOSPITAL. THE IDENTIFIED DEFECT/FAILURE COULD HAVE LED TO DEATH FOR OBVIOUS REASONS. IT WAS NOT CLEARLY VISIBLE DURING THE PROCEDURE. THE PATIENT'S ADMITTING DIAGNOSIS WAS ISCHEMIC STROKE, THE PATIENT'S NEUROLOGICAL CONDITION WAS DETERIORATING BEFORE THE PROCEDURE. THERE WAS NO DAMAGE TO THE DEVICE. IT WAS FOUND TO BE DEFECTIVE/MALFUNCTIONING. THE CAUSE OF THE SUBARACHNOID HEMORRHAGE WAS NOT DETERMINED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT THE PATIENT UNDERWENT MECHANICAL THROMBECTOMY OF THE RIGHT MIDDLE CEREBRAL ARTERY, SEGMENT M1/M2. THE STENT-RETRIEVER WAS SELECTED ACCORDING TO THE MANUFACTURER'S RECOMMENDATIONS (3X40). USING THE STANDARD TECHNIQUE, IN ACCORDANCE WITH THE INSTRUCTIONS PROVIDED (IFU), THE DEVICE WAS PREPARED, DELIVERED AT THE LEVEL OF THE THROMBUS, AND THEN OPENED IN THE THROMBUS. SMOOTH COURSE, WITHOUT EXCESSIVE RESISTANCE. IN THE NEXT STEPS, THE DEVICE WAS REMOVED USING THE STANDARD TECHNIQUE USING SIMULTANEOUS ASPIRATION FROM THE DISTAL ACCESS CATHETER AND THE GUIDING CATHETER. THIS PART OF THE PROCEDURE ALSO PROCEEDED WITHOUT UNUSUAL RESISTANCE. A FRAGMENT OF THROMBUS WAS FOUND ON THE TOOL. THE ANGIOGRAPHY PERFORMED DID NOT REVEAL RECANALIZATION (I.E. ONLY A FRAGMENT OF THE THROMBUS WAS REMOVED). IN ACCORDANCE WITH THE MANUFACTURER'S INSTRUCTIONS, THE STENT-RETRIEVER WAS PREPARED FOR THE NEXT USE, DURING WHICH IT WAS FOUND THAT ONE OF THE TWO LEGS ATTACHING THE STENT-RETRIEVER TO ITS GUIDE (THE PUSHING WIRE IN THE MANUFACTURER'S NOMENCLATURE) WAS DETACHED AND BENT. IN THE NEXT STEPS, AFTER REPLACING THE STENT-RETRIEVER, THE THROMBUS WAS REMOVED, ACHIEVING RECANALIZATION OF THE VESSEL. A CONTROL CT SCAN OF THE HEAD REVEALED SIGNIFICANT SUBARACHNOID BLEEDING. THE PATIENT PASSED AWAY. ANCILLARY DEVICES INCLUDE A PHENOM 21/160 CATHETER, SYNCHRO2 SOFT 0.014IN X 300CM MICROWIRE AND SOFIA LUS 6F/125CM CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1600309 SOLITAIRE FR4 CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 SFR4-3-40-10 B689977

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Unknown Death SEE H11...