BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 17715239 · Received September 8, 2023

    Report

    Report Number
    2029214-2023-01633
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    January 9, 2023
    Report Date
    September 8, 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

    A2. REPORTED PATIENT AGE (72 YEARS) IS REPRESENTATIVE OF THE MEAN AGE OF PATIENTS INCLUDED IN THE STUDY "PSEUDO-OCCLUSION" SUBGROUP. A3. REPORTED PATIENT SEX (FEMALE) IS REPRESENTATIVE OF THE MAJORITY OF PATIENT IN THE STUDY "PSEUDO-OCCLUSION" SUBGROUP. B3. EARLIEST DATE OF PUBLICATION IS USED FOR REPORTED DATE OF EVENT. ASSOCIATED WITH MDRS: 2029214-2023-01628, 2029214-2023-01629, 2029214-2023-01630, 2029214-2023-01631, <(>&<)> 2029214-2023-01632. 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

    NI, H., YANG, T., JIA, Z., SHI, H., LIU, S., <(>&<)> ZHAO, L. (2023). OUTCOMES IN ACUTE ISCHEMIC STROKE PATIENTS UNDERGOING ENDOVASCULAR THROMBECTOMY: CERVICAL INTERNAL CAROTID ARTERY PSEUDO-OCCLUSION VS. TRUE OCCLUSION. FRONTIERS IN NEUROLOGY, 13, 1106358. HTTPS: //DOI.ORG/10.3389/FNEUR.2022.1106358 MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND A RETROSPECTIVE ANALYSIS OF PATIENTS WITH APPARENT CERVICAL INTERNAL CAROTID ARTERY (CICA) WHO UNDERWENT THROMBECTOMY PROCEDURES BETWEEN JANUARY 2016 AND AUGUST 2021. 146 PATIENTS WERE ULTIMATELY INCLUDED IN THE STUDY GROUP. OF THE 146 PATIENTS, 79 HAD PSEUDO-OCCLUSION (PO) AND 67 HAD TRUE OCCLUSION (TO). FOR ALL PATIENTS, AN INITIAL ANGIOGRAPHIC RUN WAS COMPLETED TO IDENTIFY WHETHER THE CICA WAS TRULY OCCLUDED AND TO ASCERTAIN THE ETIOLOGY OF THE OCCLUSION. FOR CASES OF PSEUDO-OCCLUSION A REACT ASPIRATION CATHETER WAS ADVANCED INTO THE DISTAL ICA WITH SYNCHRONOUS MANUAL ASPIRATION. IF ASPIRATION FAILED TO RECANALIZE THE OCCLUDED ICA OF THROMBUS MOVED TO M1 OR PROXIMAL M2, MECHANICAL THROMBECTOMY WITH A SOLITAIRE STENT WAS PERFORMED. IF RESIDUAL SEVERE INTRACRANIAL STENOSIS WAS IDENTIFIED AFTER THROMBECTOMY, BALLOON ANGIOPLASTY WAS PERFORMED AND INTRAVENOUS (IV) TIROFIBAN WAS ADMINISTERED. THERE WAS NO SPECIFICATION IN THE ARTICLE WHICH PATIENTS, IF ANY, REQUIRED MECHANICAL THROMBECTOMY WITH A SOLITAIRE STENT RETRIEVER. THERE WAS ALSO NO SPECIFICATION WHICH PATIENTS, IF ANY, REQUIRED BALLOON ANGIOPLASTY AFTER THROMBECTOMY. SUCCESSFUL RECANALIZATION WAS ACHIEVED IN 55/79 CASES. THE MAJORITY OF PATIENTS IN THE PO GROUP WERE FEMALE AND THE MEAN AGE WAS 72. ADVERSE PATIENT EVENTS IN THE CICA PO GROUP INCLUDED: - 25 PATIENTS DIED WITHIN 90 DAYS OF TREATMENT. CAUSE OF PATIENT DEATHS AND RELATIONSHIP TO THE PROCEDURE AND/OR DEVICE(S) WAS NOT SPECIFIED. - 39 PATIENTS HAD HEMORRHAGIC TRANSFORMATION, 15 OF WHICH HAD SYMPTOMATIC INTRACRANIAL HEMORRHAGE. - 51 PATIENTS HAD POOR OUTCOME AS NOTED BY MODIFIED RANKIN SCALE (MRS) SCORE OF 3-6 AT THE 3 MONTH FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502464 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 Other