BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBAR

    MDR report key: 19304728 · Received May 13, 2024

    Report

    Report Number
    2029214-2024-00909
    Event Type
    Injury
    Date Received
    May 13, 2024
    Date of Event
    January 6, 2024
    Report Date
    May 13, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    PMA / PMN Number
    K093750
    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 105-5082-130 (UNKNOWN); PRODUCT TYPE: G2: CITATION: AUTHORS: ZHANG, L., HE, X., LI, K., LING, L., PENG, M., HUANG, L., & LIU, Y.. BALLOON ANGIOPLASTY AS FIRST-CHOICE RECANALIZATION STRATEGY FOR INTRACRANIAL ATHEROSCLEROSIS-RELATED EMERGENT LARGE VESSEL OCCLUSION WITH SMALL CLOT BURDEN.. NEURORA DIOLOGY: A JOURNAL DEDICATED TO NEUROIMAGING AND INTE 66(3), 399¿407 2024. DOI:10.1007/S00234-023-03278-8 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.

    Description of Event or Problem · 0

    ZHANG, L., HE, X., LI, K., LING, L., PENG, M., HUANG, L., & LIU, Y. (2024). BALLOON ANGIOPLASTY AS FIRST-CHOICE RECANALIZATION STRATEGY FOR INTRACRANIAL ATHEROSCLEROSIS-RELATED EMERGENT LARGE VESSEL OCCLUSION WITH SMALL CLOT BURDEN. NEURORADIOLOGY: A JOURNAL DEDICATED TO NEUROIMAGING AND INTERVENTIONAL NEURORADIOLOGY, 66(3), 399¿407. HTTPS://DOI.ORG/10.1007/S00234-023-03278-8 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF DISSECTION, SYMPTOMATIC SUBARACHNOID HEMORRHAGE, THROMBUS FRAGMENTATION, AND DEATH IN ASSOCIATION WITH MECHANICAL THROMBECTOMY AND/OR BALLOON ANGIOPLASTY USING THE REBAR 27 CATHETER. THE PURPOSE OF THIS ARTICLE WAS TO EXPLORE THE SAFETY AND EFFICACY OF BALLOON ANGIOPLASTY AS THE FIRST-CHOICE RECANALIZATION STRATEGY FOR ICAS-ELVO WITH SMALL CLOT BURDEN. THE AUTHORS REVIEWED 76 CASES OF PATIENTS TREATED FOR STROKES USING BALLOON ANGIOPLASTY AND/OR MECHANICAL THROMBECTOMY.  OF THE 76 PATIENTS, 50 PATIENTS CHOSE DIRECT BALLOON ANGIOPLASTY AND 26 CHOSE MECHANICAL THROMBECTOMY AS FIRST-CHOICE TREATMENT.  THE AVERAGE AGE WAS 65 YEARS, 18 WERE FEMALE AND 58 WERE MALE. THE STUDY SUGGESTS THAT IT MAY BE FEASIBLE TO CHOOSE THE PRIMARY RECANALIZATION STRATEGY FOR PATIENTS WITH ICAS-ELVO BASED ON THE CLOT BURDEN JUDGED BY THE MICROCATHETER ¿FIRST-PASS EFFECT.¿ OVERALL, FIRST PASS RECANALIZATION OCCURRED IN 33 PATIENTS (27 PATIENTS IN BALLOON ANGIOPLASTY GROUP AND 6 PATIENTS IN MECHANICAL THROMBECTOMY GROUP.) THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE REBAR 27. IN ADDITION, OVERALL, 75 PATIENTS HAD A TICI SCORE >2B, 52 PATIENTS HAD A TICI SCORE >2C. THE PATIENT 90-DAY MRS SCORES, INCLUDED 27 PATIENTS WITH A MRS SCORE OF 0-1 AND 50 PATIENTS WITH A MRS SCORE OF 0-2. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: DISSECTION IN 15 PATIENTS SYMPTOMATIC INTRACRANIAL HEMORRHAGE IN 10 PATIENTS THROMBUS FRAGMENTATION IN 5 PATIENTS DEATH IN 7 PATIENTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613213 REBAR CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 105-5082-130 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other