BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBAR

    MDR report key: 18026287 · Received October 27, 2023

    Report

    Report Number
    2029214-2023-02124
    Event Type
    Injury
    Date Received
    October 27, 2023
    Date of Event
    February 23, 2022
    Report Date
    October 27, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID UNK-NV-SAB; PRODUCT ID UNK-NV-SAB; PRODUCT ID UNK-NV-SAB; G2: CITATION: AUTHORS: JUN HUANG, MING ZHANG, QINGBIN NIE, XINYE ZHANG, XIN HE, YUFENG YANG, AND GENGSHENG MAO. EFFICACY OF INTRAVENOUS THROMBOLYSIS COMBINED WITH MECHANICAL STENT INTERVENTIONAL THROMBECTOMY ON ACUTE ISCHEMIC STROKE. JOURNAL OF MEDICAL BIOCHEMISTRY 41 (4) 2022. DOI: 10.5937/JOMB0-35652 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. 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

    JUN HUANG, MING ZHANG, QINGBIN NIE, XINYE ZHANG, XIN HE, YUFENG YANG, AND GENGSHENG MAO; JOURNAL OF MEDICAL BIOCHEMISTRY; 2022; 41 (4); EFFICACY OF INTRAVENOUS THROMBOLYSIS COMBINED WITH MECHANICAL STENT INTERVENTIONAL THROMBECTOMY ON ACUTE ISCHEMIC STROKE; DOI: 1 0.5937/JOMB0-35652 MEDTRONIC RECEIVED INFORMATION THAT PATIENT'S TREATED WITH SOLITAIRE AB STENTS AND REBAR18 CATHETERS HAVING COMPLICATIONS. THE STUDY AIMED TO INVESTIGATE THE EFFICACY AND SAFETY OF INTRAVENOUS THROMBOLYSIS COMBINED WITH MECHANICAL STENT INTERVENTIONAL THROMBECTOMY IN THE TREATMENT OF ACUTE ISCHEMIC STROKE, AND ITS INFLUENCE ON NEUROLOGICAL FUNCTION, IMMUNOLOGICAL FUNCTION AND PROGNOSIS OF PATIENTS, SO AS TO PROVIDE GREAT EVIDENCE FOR THE TREATMENT OF SUCH PATIENTS. A TOTAL OF 118 PATIENTS WITH ACUTE ISCHEMIC STROKE TREATED IN THE HOSPITAL FROM THE STUDY FROM JANUARY 2016 TO MARCH 2021 WERE SELECTED AND DIVIDED INTO CONTROL GROUP (N=59) AND THROMBECTOMY GROUP (N=59) ACCORDING TO DIFFERENT TREATMENT METHODS. THE THROMBECTOMY GROUP HAD 39 MALES AND 20 FEMALES.  TREATMENT: THE CONTROL GROUP RECEIVED INTRAVENOUS THROMBOLYTIC THERAPY. IN THROMBECTOMY GROUP, MECHANICAL THROMBECTOMY WAS ADOPTED BASED ON THE TREATMENT IN CONTROL GROUP. UNDER THE GUIDANCE OF GUIDE WIRE, A 6F GUIDING CATHETER WAS INSERTED AND SENT TO THE DISEASED BLOOD VESSEL. UNDER THE GUIDANCE OF SILVERSPEED-14 MICRO-GUIDE WIRE, A REBAR18 MICROCATHETER WAS INSERTED THROUGH THE THROMBUS, PASSED OVER THE OCCLUDED SEGMENT OF CEREBRAL ARTERY AND REACHED INTO THE DISTAL BRANCH OF THE DISEASED BLOOD VESSEL. BASED ON THE ACTUAL SITUATION OF PATIENTS, AN APPROPRIATE SOLITAIRE AB STENT WAS PLACED FOR MECHANICAL THROMBECTOMY FOR NO MORE THAN 3 TIMES. AFTER THE THROMBUS WAS REMOVED, THE REBAR18 MICRO CATHETER WAS WITHDRAWN, AND 30 ML OF BLOOD WAS DRAWN BACK FROM THE GUIDING CATHETER. ANGIOGRAPHY WAS PERFORMED AGAIN TO CONFIRM WHETHER THE FLOW OF THE DISEASED BLOOD VESSEL IS UNOBSTRUCTED. IN THE CASE OF RESIDUAL STENOSIS, ANGIOPLASTY WAS PERFORMED ACCORDING TO THE SITUATION OF PATIENTS, AFTER WHICH BLEEDING WAS STOPPED USING CLOSURE DEVICES AND THE PUNCTURE POINT WAS BANDAGED. AT 24 H AFTER TREATMENT, ANTI-PLATELET AGGREGATION THERAPY (ORAL ADMINISTRATION OF ASPIRIN 100 MG/D AND CLOPIDOGREL 75 MG/D) WAS ADOPTED IN BOTH GROUPS FOR 3 CONSECUTIVE MONTHS. THEN THE MEDICATION WAS ADJUSTED BASED ON THE RESULTS OF REEXAMINATION. RESULTS: THE CLINICAL EFFICACY WAS EVALUATED AT 3 MONTHS AFTER TREATMENT. IN THROMBECTOMY GROUP, THERE WERE 25 (42.4%) CURE CASES, 15 (25.4%) MARKEDLY EFFECTIVE CASES, 14 (23.7%) EFFECTIVE CASES AND 5 (8.5%) INEFFECTIVE CASES, WITH THE EFFECTIVE RATE BEING 93.2 % (54/59). AFTER TREATMENT, GASTROINTESTINAL BLEEDING OCCURRED IN 3 CASES AND SKIN AND MUCOSAL ECCHYMOSIS OCCURRED IN 4 CASES IN THROMBECTOMY GROUP. THE NIHSS SCORE AND MRS SCORE WERE OBVIOUSLY LOWER IN THROMBECTOMY GROUP THAN THOSE IN CONTROL GROUP AT 1 MONTH AFTER TREATMENT. A HIGHER NIHSS SCORE CORRESPONDS TO THE SEVERER NEUROLOGICAL IMPAIRMENT. THE BARTHEL INDEX WAS OBVIOUSLY HIGHER IN THROMBECTOMY GROUP THAN THAT IN CONTROL GROUP AT 1 AND 2 MONTHS AFTER TREATMENT, WHILE RESULTS AT 3 MONTHS AFTER TREATMENT SHOWED NO STATISTICALLY SIGNIFICANCE BETWEEN THE TWO GROUPS. IN THROMBECTOMY GROUP, THE PROPORTION OF PATIENTS IN TICIGRADE 2B WAS 64.4%, THE RESIDUAL STENOSIS RATE WAS 18.6%, THE 24 HOUR SYMPT OMATIC INTRACRANIAL HEMORRHAGE RATE WAS 6.8%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2221378 REBAR CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-REBAR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other