BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 18374205 · Received December 21, 2023

    Report

    Report Number
    2029214-2023-02430
    Event Type
    Death
    Date Received
    December 21, 2023
    Date of Event
    April 12, 2023
    Report Date
    December 20, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: LUO, G., YAN, X., XIAO, G., WEI, L., NAI BI JIANG, Y. L. K., MA, R., CHEN, W., FANG, C., ZHOU, Z., WAN, J., PENG, Y., ZHANG, G., ZHAO, J., LI, L., YUAN, H., WU, J., LI, B., ZHANG, F., CHENG, Y., MIA. COMPARING A NOVEL CATFISH FLOW RESTORATION DEVICE AND THE SOLITAIRE STENT RETRIEVER FOR THROMBECTOMY REVASCULARISATION IN EMERGENT LARGEVESSEL OCCLUSION STROKE: A PROSPECTIVE RANDOMISED CONTROLLED STU. STROKE AND VASCULAR NEUROLOGY 2023. DOI:10.1136/SVN-2022-002036 A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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 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

    LUO G, YAN X, XIAO G, ET AL. COMPARING A NOVEL CATFISH FLOW RESTORATION DEVICE AND THE SOLITAIRE STENT RETRIEVER FOR THROMBECTOMY RE VASCULARIZATION IN EMERGENT LARGE VESSEL OCCLUSION STROKE: A PROSPECTIVE RANDOMISED CONTROLLED STUDY. STROKE AND VASCULAR NEUROLOGY. APRIL 2023. DOI:10.1136/SVN-2022-002036 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH THE SOLITAIRE STENT. THE PURPOSE OF THIS ARTICLE WAS TO COMPARE THE CATFISH STENT RETRIEVER AND THE SOLITAIRE STENT RETRIEVER FOR MECHANICAL THROMBECTOMY (MT) EFFICACY AND SAFETY IN PATIENTS WITH ACUTE INTRACRANIAL EMERGENT LARGE VESSEL OCCLUSION (ELVO) STROKE. THIS WAS A RANDOMIZED, PROSPECTIVE, PARALLEL GROUP, MULTICENTER, OPEN-LABEL, NON-INFERIORITY STUDY CONDUCTED AT 18 SITES IN CHINA. BETWEEN (B)(6) 2021, 118 AND 120 PATIENTS WERE RANDOMLY ALLOCATED TO THE CATFISH AND SOLITAIRE GROUPS, RESPECTIVELY. ELEVEN PATIENTS DID NOT RECEIVE THE ASSIGNED INTERVENTION, MAINLY BECAUSE THE SYMPTOMS WERE RELIEVED BEFORE THE STENT RETRIEVER PRO CEDURE (N=2), THE MAJORITY OF THE THROMBUS SHOWED SPONTANEOUS LYSIS ON DSA IMAGES BEFORE MT (N=7), BILATERAL DISEASE REVEALED BY MRI (N=1) AND USE OF AN ASPIRATION FIRST APPROACH ONLY FOR THROMBECTOMY (N=1). IN ADDITION, NO PATIENTS CROSSED OVER TO THE CONTRALATERAL GROUP. THEREFORE, THE PER-TREATMENT POPULATION HAD 227 CASES, WITH 113 AND 114 PATIENTS ALLOCATED TO THE CATFISH AND SOLITAIRE GROUPS, RESPECTIVELY. THE PATIENTS AVERAGED 62.2 YEARS OLD AND 72 WERE MEN IN THE SOLITAIRE GROUP.  THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE SOLITAIRE DEVICES. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: 18 CASES OF ALL-CAUSE DEATH BY 90-DAYS -12 CASES OF STUDY DEVICE-ASSOCIATED SERIOUS ADVERSE EVENTS -1 CASE OF LOCAL PUNCTURE SITE HEMATOMA -3 CASES OF EMBOLIZATION IN A NEW VASCULAR TERRITORY -1 CASE OF ATRIAL PERFORATION -9 CASES OF VASOSPASM -4 CASES OF SUBARACHNOID HEMORRHAGE 9 CASES OF SYMPTOMATIC HEMORRHAGE PRIMARY ANGIOGRAPHIC EFFICACY OUTCOME SHOWING THAT PATIENTS ACHIEVED AN MTICI SCORE OF 2B/3 AND RECANALIZATION AFTER ALL ENDOVASCULAR PROCEDURES IN SOLITAIRE GROUP WAS 87.7% (100/114) RESCUE TECHNIQUES AFTER FIRST LINE THERAPY WERE PERFORMED IN 19 (14.2%) CASES OF THE SOLITAIRE GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298184 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Death