BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBAR

    MDR report key: 21554758 · Received March 7, 2025

    Report

    Report Number
    2029214-2025-00600
    Event Type
    Injury
    Date Received
    March 7, 2025
    Date of Event
    February 22, 2023
    Report Date
    March 7, 2025
    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

    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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ZHAO, Y., JIA, S., LI, J., GENG, J., WANG, Y., & CUI, X.; INTERNATIONAL JOURNAL OF NEUROSCIENCE; 2024; 134(9); A CASE OF ACUTE BASILAR ARTERY OCCLUSION DUE TO ATHEROSCLEROTIC DISEASE REVASCULARIZED BY DRUG-COATED BALLOON DILATION.; DOI.ORG/10.1080/00207454.2023.2203837 LITERATURE WAS REVIEWED REGARDING: "A CASE OF ACUTE BASILAR ARTERY OCCLUSION DUE TO ATHEROSCLEROTIC DISEASE REVASCULARIZED BY DRUG-COATED BALLOON DILATION." THE STUDY AIMED TO EVALUATE THE EFFECTIVENESS AND SAFETY OF DRUG-COATED BALLOONS (DCB) FOR TREATING ACUTE BASILAR ARTERY OCCLUSION (ABAO) DUE TO ATHEROSCLEROTIC DISEASE. THE TIME FRAME OF THIS STUDY WAS: THE PATIENT PRESENTED ON FEBRUARY 22, 2023, AND FOLLOW-UP ASSESSMENTS WERE MADE UP TO 90 DAYS POST-SURGERY. MULTIPLE MANUFACTURER'S DEVICES WERE USED IN THE STUDY. THE FOLLOWING MEDTRONIC DEVICES WERE USED: NAVIEN CATHETER, REBAR18 CATHETER. THERE ARE NO REPORTED DEATHS IN THE STUDY. AMONG PATIENT ADVERSE EVENTS INCLUDED: POSTOPERATIVE DAY 1: NEW BILATERAL CEREBELLAR ACUTE ISCHEMIC STROKE. POSTOPERATIVE DAY 3: MULTIPLE FRESH CEREBRAL INFARCTS IN VARIOUS BRAIN REGIONS. LOCAL LUMINAL STENOSIS OF THE MRA BASILAR ARTERY WAS OBSERVED POST-OPERATIVE DAY 2: INCOMPLETE GAZE OF BOTH EYES TO THE RIGHT AND RIGHT LIMB MUSCLE STRENGTH GRADE 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098134 REBAR CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-REBAR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other