BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEX CATHETER

    MDR report key: 21649689 · Received March 20, 2025

    Report

    Report Number
    2029214-2025-00720
    Event Type
    Injury
    Date Received
    March 20, 2025
    Date of Event
    June 17, 2024
    Report Date
    March 19, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: LIN, T.-M., WU, C.-H., CHUNG, C.-P., YU, K.-W., TAI, W.-A., LUO, C.-B., LIRNG, J.-F., & CHANG, F.-C. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND STENTING FOR SEVERE STENOSIS OF THE INTRACRANIAL CAROTID ARTERY AND ITS BRANCHES: COMPARISON OF THE WINGSPAN STENT VS THE CREDO STENT. JOURNAL OF THE CHINESE MEDICAL ASSOCIATION 87(9):878-884 2024. DOI:10.1097/JCMA.0000000000001131 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

    LITERATURE WAS REVIEWED REGARDING: "COMPARISON OF THE WINGSPAN STENT VS THE CREDO STENT FOR SEVERE STENOSIS OF THE INTRACRANIAL CAROTID ARTERY AND ITS BRANCHES." THE TIME FRAME OF THIS STUDY WAS: THE STUDY ANALYZED PATIENTS WHO UNDERWENT PERCUTANEOUS ANGIOPLASTY AND STENTING (PTAS) BETWEEN 2018 AND 2022. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION: YES, THE STUDY COMPARED DEVICES FROM TWO DIFFERENT MANUFACTURERS: THE WINGSPAN STENT SYSTEM (BOSTON SCIENTIFIC) AND THE CREDO STENT SYSTEM (ACANDIS GMBH). THE FOLLOWING MEDTRONIC DEVICES WERE USED: NAVIEN INTERMEDIATE CATHETERS WERE USED IN AN UNKNOWN NUMBER OF PROCEDURES. DEATHS: NO DEATHS WERE NOTED WITHIN 30 DAYS AFTER THE PROCEDURES OR DURING THE 1-YEAR FOLLOW-UP PERIOD. AMONG PATIENT ADVERSE EVENTS INCLUDED: ¿ ONE PATIENT SUDDENLY DEVELOPED HYPERTENSION EXCEEDING 200 MM HG AFTER PASSING THE MICROWIRE THROUGH THE STENOSIS. SUBSEQUENT CONE BEAM CT REVEALED MINIMAL SUBARACHNOID HEMORRHAGE (SAH) ALONG THE SYLVIAN FISSURE. THIS RESULTED IN EARLY TERMINATION OF THE PROCEDURE WITHOUT STENTING. NO PROGRESSION OF THE HEMORRHAGE WAS OBSERVED ON FOLLOW-UP CT 1 DAY LATER, AND THE PATIENT WAS DISCHARGED 3 DAYS LATER WITH NO NEW NEUROLOGICAL DEFICITS. ¿ ONE PATIENT UNDERWENT SUCCESSFUL PTAS, WITH THE RESIDUAL STENOSIS DECREASING FROM 95% TO 30%. HOWEVER, A SMALL AMOUNT OF SAH IN THE SYLVIAN FISSURE WAS NOTED DURING THE POSTSTENTING EVALUATION. THE PATIENT PRESENTED WITH POSTPROCEDURAL HEADACHE BUT HAD NO NEW NEUROLOGICAL DEFICITS AND WAS DISCHARGED AFTER CONSERVATIVE TREATMENT. ¿ TWENTY PATIENTS HAD SILENT EMBOLIC ISCHEMIC LESION OF IPSILATERAL MCA TERRITORY ON DIFFUSION-WEIGHTED IMAGING. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371764 REFLEX CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-RFX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other