BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 18380548 · Received December 21, 2023

    Report

    Report Number
    2029214-2023-02442
    Event Type
    Death
    Date Received
    December 21, 2023
    Date of Event
    July 12, 2022
    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

    SEE ATTACHMENTS FOR LITERATURE ARTICLE. 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 J, WU D, LI Z, XIE D, HUANG J, SONG J, LUO W, LIU S, LI F, ZI W, HUANG Q, LUO J, AND KONG D; FRONTIERS IN NEUROLOGY; 2022; 13:992396; WHICH IS THE MOST EFFECTIVE RESCUE TREATMENT AFTER THE FAILURE OF MECHANICAL THROMBECTOMY FOR ACUTE BASILAR ARTERY OCCLUSION?; DOI:10.3389/FNEUR.2022.992396 MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE THAT PATIENT TREATED WITH SOLITAIRE STENTS HAD COMPLICATIONS.  THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECTIVENESS AND SAFETY OF RESCUE THERAPY, A THERAPY IN WHICH RESCUE DEVICES SUCH AS BALLOON ANGIOPLASTY, APOLLO STENT, WINGSPAN STENT, SOLITAIRE STENT, OR OTHER SELF-EXPANDING STENTS ARE USED AFTER THE FAILURE OF MECHANICAL THROMBECTOMY (MT) AND TO DETERMINE THE MOST EFFECTIVENESS RESCUE MEASURE FOR ACUTE BASILAR ARTERY OCCLUSION (BA O) AFTER THE FAILURE OF MT.  THE BASILAR STUDY WAS A NATIONWIDE PROSPECTIVE REGISTRY CONDUCTED IN 47 COMPREHENSIVE STROKE CENTERS IN CHINA BETWEEN (B)(6) 2019.  PATIENTS WERE ELIGIBLE FOR INCLUSION IF THEY WERE 18 YEARS OR OLDER WITH ACUTE ISCHEMIC STROKE CAUSED BY BAO WITHIN 24 HOUR OF ESTIMATED OCCLUSION TIME, CONFIRMED BY COMPUTED TOMOGRAPHIC ANGIOGRAPHY, MAGNETIC RESONANCE ANGIOGRAPHY, OR DIGITAL SUBTRACTION ANGIOGRAPHY.  ALL ELIGIBLE PATIENTS RECEIVED EVT IN COMBINATION WITH SMT. TREATMENT MODALITIES OF EVT, INCLUDING MECHANICAL THROMBECTOMY WITH STENT RETRIEVERS AND/OR THROMBO-ASPIRATION, BALLOON ANGIOPLASTY, STENTING, INTRA-ARTERIAL THROMBOLYSIS, OR A COMBINATION OF THESE APPROACHES, WERE CHOSEN AT THE DISCRETION OF NEUROINTERVENTIONALISTS. RESCUE TREATMENT CAN BE DEFINED AS THE USE OF RESCUE DEVICES, SUCH AS BALLOON ANGIOPLASTY, APOLLO STENT, WINGSPAN STENT, SOLITAIRE STENT, AND OTHER SELF-EXPANDING STENTS AFTER THE FAILURE OF MT. BASED ON RECANALIZATION WITH OR WITHOUT RESCUE THERAPY, THE PARTICIPANTS WERE DIVIDED INTO THREE GROUPS: THE NON-RECANALIZED GROUP, THE RECANALIZED WITHOUT A RESCUE THERAPY GROUP, AND THE RECANALIZED WITH A RESCUE THERAPY GROUP. THE CLINICAL OUTCOMES WE MEASURED INCLUDED SHORT- AND LONG-TERM OUTCOMES. THE PRIMARY OUTCOME WAS A FAVORABLE FUNCTIONAL OUTCOME DEFINED AS AN MRS SCORE OF 0¿3 AT 90 DAYS. SECONDARY OUTCOMES WERE FUNCTIONAL INDEPENDENCE (DEFINED AS AN MRS SCORE OF 0¿2) AT 90 DAYS, FAVORABLE OUTCOMES AT 1 YEAR, MORTALITY WITHIN 90 DAYS OR 1 YEAR, RE-OCCLUSION WITHIN 24 H, AND SYMPTOMATIC INTRACEREBRAL HEMORRHAGE (SICH) WITHIN 48 H BASED ON THE HEIDELBERG BLEEDING CLASSIFICATION. IN THE BASILAR REGISTRY INVOLVING 829 PATIENTS, WE INCLUDED 585 PATIENTS TREATED WITH EVT AND WITH AVAILABLE MTICI SCORES. AMONG THEM, RECANALIZATION FAILURE OCCURRED IN 112 PATIENTS AND SUCCESSFUL RECANALIZATION IN 473 PATIENTS, WITH 218 PATIENTS RECEIVING RESCUE THERAPY AND 255 PATIENTS NOT RECEIVING RESCUE THERAPY. A TOTAL OF 147 PATIENTS (25.1%) WERE WOMEN AND 438 PATIENTS (74.9%) WERE MEN. RESULTS: AMONG THE PATIENTS TREATED WITH EVT, NINE PATIENTS (8.0%) IN THE NON-RECANALIZED GROUP, 111 PATIENTS (43.5%) IN THE RECANALIZED WITHOUT RESCUE THERAPY GROUP, AND 65 PATIENTS (29.8%) IN THE RECANALIZED WITH RESCUE THERAPY GROUP ACHIEVED FAVORABLE FUNCTIONAL OUTCOMES AT 90 DAYS. COMPARED WITH THE NON-RECANALIZED GROUP, THE RECANALIZED WITHOUT RESCUE THERAPY AND THE RECANALIZED WITH RESCUE THERAPY GROUPS HAD OTHER BETTER SHORT- AND LONG-TERM OUTCOMES. HOWEVER, COMPARED WITH THE RECANALIZED WITHOUT RESCUE THERAPY GROUP, THE RECANALIZED WITH RESCUE THERAPY GROUP DID NOT SHOW WORSE SHORT- AND LONG-TERM OUTCOMES. ACCORDING TO THE RESCUE DEVICES USED, THE PATIENTS TREATED WITH RESCUE THERAPY WERE DIVIDED INTO FOUR SUBGROUPS: BALLOON ANGIOPLASTY, APOLLO STENT, SOLITAIRE STENTS, AND OTHER SELF-EXPANDING STENTS. NO DIFFERENCE WAS FOUND AMONG THE CHARACTERISTICS OF PATIENTS USING DIFFERENT RESCUE DEVICES. THE SOLITAIRE STENT HAD A SIGNIFICANTLY LOWER RATE OF FAVORABLE OUTCOMES AT 90 DAYS THAN BALLOON ANGIOPLASTY AND OTHER SELF-EXPANDING STENTS. ALSO, THESOLITAIRE STENT HAD A SIGNIFICANTLY HIGHER RATE OF MORTALITY AT 90 DAYS THAN THE APOLLO STENT AND OTHER SELF-EXPANDING STENTS. SIMILAR TRENDS WERE OBSERVED IN ANALYSES OF THE OCCLUSION OF THE MIDDLE BA AND IN ANALYSES OF THE OCCLUSION OF THE PROXIMAL BA OR SEGMENT 4 OF THE VERTEBRAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035420 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Death