BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBAR

    MDR report key: 19130438 · Received April 18, 2024

    Report

    Report Number
    2029214-2024-00680
    Event Type
    Injury
    Date Received
    April 18, 2024
    Date of Event
    October 6, 2022
    Report Date
    September 10, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 0

    NO SPECIFIC DEVICE INFORMATION PROVIDED. NO EVENT DATE WAS PROVIDED THE EVENT DATE USED WAS THE DATE THE ARTICLE WAS PUBLISHED. 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

    RAYNALD, YANG,H., TONG, X.,HUO, X., LI, X., LIU, L., SUI, B., QU, H., DONG, K., WANG, Y., WANG, S., MIAO, Z., MO, D. STENTING VERSUS MEDICAL TREATMENT FOR IDIOPATHIC INTRACRANIAL HYPERTENSION: A MATCHED-CONTROL STUDY. J NEUROINTERVENT SURG. 2023. 15:1021¿1026. DOI: 10.1136/NEURINTSURG-2022-019191 SUMMARY: THIS PROSPECTIVE COHORT STUDY COMPARED THE OUTCOMES OF STENTING AND MEDICAL TREATMENT FOR PATIENTS WITH IDIOPATHIC INTRACRANIAL HYPERTENSION (IIH) AND VENOUS SINUS STENOSIS (VSS). IN THIS SINGLE-CENTER COHORT STUDY, PATIENTS WITH IIH AND VSS WERE EVALUATED BETWEEN JANUARY 2014 AND DECEMBER 2019 WITH FOLLOW-UP PERIODS OF 1, 3, AND 6 MONTHS. THE PATIENTS RECEIVED EITHER STENTING OR MEDICAL TREATMENT. THE TWO GROUPS UNDERWENT 1:1 MATCHING USING PROPENSITY SCORE ANALYSIS, AND THE CLINICAL OUTCOMES WERE COMPARED. FOLLOWING 1:1 MATCHING, 36 PATIENTS WHO UNDERWENT STENTING AND 36 WHO UNDERWENT MEDICAL TREATMENT WERE MATCHED. THE MEDIAN IMPROVEMENTS IN THE PAPILLEDEMA FRISÉN GRADE WERE GREATER IN THE STENTING GROUP AT 1MONTH (-2 VS 0), 3 MONTHS (-3 VS -1), AND 6 MONTHS (-3 VS -1) THAN IN THE MEDICAL TREATMENT GROUP. PATIENTS WHO RECEIVED STENTING TREATMENT HAD A SIGNIFICANTLY HIGHER PREVALENCE OF COMPLETE RESOLUTION OF THEIR RESPECTIVE SYMPTOMS (HEADACHE, TINNITUS, OR VISUAL DISTURBANCES) AT 3 MONTHS (58.3% VS 13.9%, OR 8.68, 95% CI 2.74 TO 27.52) AND 6 MONTHS (80.6% VS 22.2%, OR 14.50, 95%CI 4.64 TO 45.32) THAN THOSE RECEIVING MEDICAL TREATMENT. THIS MATCHED-CONTROL STUDY SHOWS THAT STENTING HAS A GREATER EFFICACY RATE AND RAPID RESOLUTION OF PAPILLEDEMA AND ITS RESPECTIVE SYMPTOMS COMPARED WITH MEDICAL TREATMENT. REPORTED EVENTS: AFTER THE STENTING TREATMENT, 24 PATIENTS HAD GASTROINTESTINAL DISCOMFORT, 11 PATIENTS HAD MENORRHAGIA, THREE PATIENTS HAD GINGIVAL BLEEDING, AND ONE PATIENT HAD FUNDUS HEMORRHAGE. PULMONARY INFECTION OCCURRED IN ONE PATIENT. A PSEUDOANEURYSM AT THE FEMORAL PUNCTURE SITE WAS FOUND IN ONE PATIENT. OF ALL THE PATIENTS WHO RECEIVED STENTING TREATMENT, THREE RECEIVED A SECOND STENT PLACEMENT. ONE PATIENT HAD BILATERAL PAPILLEDEMA AND A SECOND STENT WAS PLACED AT THE CONTRALATERAL VENOUS SINUS. ANOTHER PATIENT SHOWED IMPROVED SYMPTOMS AFTER STENT PLACEMENT, WITH THE SYMPTOMS WORSENING LATER. ONE YEAR AFTER STENTING SIGNIFICANT RE-STENOSIS WAS OBSERVED AND FURTHER STENT PLACEMENT WAS PERFORMED. IN ANOTHER PATIENT, SYMPTOMS IMPROVED AFTER THE FIRST STENT PLACEMENT; HOWEVER, THERE WAS NO RESOLUTION OF THE PAPILLEDEMA AND OCCASIONAL HEADACHE AND BLURRED VISION REMAINED. THREE MONTHS LATER, A SECOND STENT PLACEMENT WAS PERFORMED AND NO WORSENING OF BLURRED VISION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606579 REBAR CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-REBAR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening