BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 21081553 · Received January 6, 2025

    Report

    Report Number
    2029214-2025-00047
    Event Type
    Death
    Date Received
    January 6, 2025
    Date of Event
    February 11, 2024
    Report Date
    January 27, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: UNK-NV-SOLITAIRE (UNKNOWN); IMPLANT DATE: N/A; EXPLANT DATE: N/A. G2: CITATION: AUTHORS: LEE, H. G., YI, H. J., SHIN, D.-S., & KIM, B.-T. COMPARISON OF 4 MM-SIZED AND 3 MM-SIZED STENT RETRIEVERS IN MECHANICAL THROMBECTOMY FOR M2 OCCLUSION. CURRENT NEUROVASCULAR RESEARCH 21(2):157-165 2024. DOI:10.2174/0115672026303196240327053722. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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

    LITERATURE WAS REVIEWED REGARDING COMPARISON OF 4 MM-SIZED AND 3 MM-SIZED STENT RETRIEVERS IN MECHANICAL THROMBECTOMY FOR M2 OCCLUSION. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. IT WAS NOT REPORTED WHICH DEVICES WERE ASSOCIATED WITH THE REPORTED COMPLICATIONS. THE FOLLOWING MEDTRONIC DEVICES WERE USED: SOLITAIRE STENT RETRIEVERS. DEATHS OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. 6 TOTAL CASES OF MORTALITY WERE REPORTED AMONG PATIENT ADVERSE EVENTS ISSUES INCLUDED: 12 CASES OF DISTAL EMBOLI, 4 CASES OF DISSECTION/PERFORATION, 6 CASES OF SYMPTOMATIC HEMORRHAGE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THE RESEARCH PEROID WAS JANUARY 2015 - JULY 2023. CORRECTIONS WAS MADE THAT SRT WAS PERFORMED WITH A 4MM AND 3MM SIZED RETRIEVABLE STENT, SUCH AS SOLITAIRE (EV3/COVIDIEN, IRVINE, CA, USA) OR TREVO (STRYKER NEUROVASCULAR, FREMONT, CA, USA). THE PRODUCT (SOLITAIRE) ITSELF DID NOT CAUSE ANY PROBLEMS AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382223 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Death SEE H11...