BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBAR

    MDR report key: 21574904 · Received March 11, 2025

    Report

    Report Number
    2029214-2025-00627
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    November 29, 2024
    Report Date
    March 11, 2025
    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

    CONTINUATION OF D10: PRODUCT ID UNK-NV-RFX (LOT: UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID 105-5082-130 (LOT: UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID UNK-NV-RFX (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A G2: CITATION: AUTHORS: XU, Z., YAN, L., XU, Y., HE, H., XU, Y., ZHANG, S., ZHU, M., WU, Y., SHUI, S.. STENTING VERSUS BALLOON ANGIOPLASTY ALONE FOR IDIOPATHIC INTRACRANIAL HYPERTENSION. QUANTITATIVE IMAGING IN MEDICINE AND SURGERY 14(12):9431-9443. 2024. DOI:10.21037/QIMS-24-1272 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. 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

    MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF HEADACHE, PAPILLEDEMA, VISUAL IMPAIRMENT, SIXTH NERVE PALSY, TINNITUS, PUNCTURE SITE HEMATOMA, STENOSIS, DISTAL STENT STENOSIS, AND DISTAL STENT THROMBOSIS IN ASSOCIATION WITH STENTING VS BALLOON ANGIOPLASTY IN PATIENTS WITH INTRACRANIAL HYPERTENSION OR VENOUS SINUS STENOSIS WHERE A REBAR 27 MICROCATHETER AND NAVIEN CATHETER WERE USED. THE TIME FRAME OF THIS STUDY WAS FROM JANUARY 2018 TO JUNE 2023. THE PURPOSE OF THIS ARTICLE WAS TO COMPARE THE CLINICAL EFFICACY OF BALLOON ANGIOPLASTY AND STENTING IN THE TREATMENT OF INTRACRANIAL HYPERTENSION AND VENOUS SINUS STENOSIS. THE AUTHORS REVIEWED 122 CASES OF PATIENTS TREATED FOR INTRACRANIAL HYPERTENSION (IIH) AND VENOUS SINUS STENOSIS (VSS); 64 PATIENTS IN GROUP S WHICH RECEIVED STENTING WITH OR WITHOUT BALLOON ANGIOPLASTY AND 58 PATIENTS IN GROUP B WHICH RECEIVED BALLOON ANGIOPLASTY ALONE. OF THE 122 PATIENTS, THE AVERAGE AGE WAS 40 YEARS, 86 WERE FEMALE (50 FEMALES IN STENT GROUP AND 36 FEMALES IN BALLOON ANGIOPLASTY GROUP) AND 36 WERE MALE (14 MALES IN STENTING GROUP AND 22 MALES IN BALLOON ANGIOPLASTY GROUP). THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE NAVIEN OR REBAR 27 CATHETERS. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: HEADACHE PAPILLEDEMA VISUAL IMPAIRMENT SIXTH NERVE PALSY TINNITUS PUNCTURE SITE HEMATOMA IN 1 PATIENT RECURRENT IN-SITU STENOSIS IN 7 PATIENTS SUCCESSFULLY MANAGED WITH BALLOON VASODILATION DISTAL STENT STENOSIS IN 2 PATIENTS FOR A PROTÉGÉ STENT DISTAL STENT THROMBOSIS IN 1 PATIENT FOR A PROTÉGÉ STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148696 REBAR CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 105-5082-130 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11...