BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBAR

    MDR report key: 22476352 · Received July 10, 2025

    Report

    Report Number
    2029214-2025-01564
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    December 28, 2024
    Report Date
    July 10, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    PORYO, M., GHEIBEH, A., RENTZSCH, A., ABDUL-KHALIQ, H., & PFEIFER, J.; JOURNAL OF CLINICAL MEDICINE; 2025; 14, 113; TRANSCATHETER EMBOLIZATION OF SYSTEMIC-TO-PULMONARY COLLATERALS: A NEW APPROACH USING CONCERTO¿ HELIX NYLON-FIBERED MICROCOILS; DOI.ORG/10.3390/JCM14010113 LITERATURE WAS REVIEWED REGARDING 'TRANSCATHETER EMBOLIZATION OF SYSTEMIC-TO-PULMONARY COLLATERALS: A NEW APPROACH USING CONCERTO HELIX NYLON-FIBERED MICROCOILS'. THE TIME FRAME OF THIS STUDY WAS JANUARY 2016 TO DECEMBER 2023. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: CONCERTO HELIX NYLON-FIBERED MICROCOILS (CHM). REBAR-18 CATHETER. A DEATH OCCURRED IN THE STUDY POPULATION. INDEPENDENT OF THE PROCEDURE, A CHILD WITH A TETRALOGY OF FALLOT AND BORDERLINE LEFT VENTRICLE DIED THREE WEEKS LATER AFTER SURGICAL CORRECTION AND POSTOPERATIVE EXTRACORPOREAL LIFE SUPPORT (DAY 20 POSTOPERATIVE). AMONG PATIENT ADVERSE EVENTS INCLUDED: VASCULAR INJURY WITH RESULTING EXTRAVASATION OF CONTRAST MEDIUM SURROUNDING THE TARGET VESSEL. FORMATION OF A STRETCHED INSTEAD OF A COILED STRUCTURE IN A PORTION OF THE DISTAL CHMS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678299 REBAR CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-REBAR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male Required Intervention