BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO

    MDR report key: 20823395 · Received December 2, 2024

    Report

    Report Number
    2029214-2024-02221
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    January 4, 2024
    Report Date
    March 5, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID UNK-NV-CONCERTO (UNKNOWN); PRODUCT TYPE: G2: CITATION: AUTHORS: YU, K.-W., WU, C.-H., LIN, T.-M., TAI, W.-A., LUO, C.-B., <(>&<)> CHANG, F.-C.. ENDOVASCULAR MANAGEMENT OF PO ST-IRRADIATED CAROTID BLOWOUT SYNDROME IN PATIENTS WITH LOWER NECK CANCERS. EUROPEAN JOURNAL OF VASCULAR <(>&<)> ENDOVASCULAR SURGERY 67(5):708-716 2024. DOI:10.1016/J.EJVS.2023.12.036 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF DEATH IS RELATED TO TUMOR PROGRESSION. OF THE ADVERSE EVENTS THAT WERE MENTIONED WITHIN THE ARTICLE, NONE OF THEM WERE RELATE DIRECTLY TO MEDTRONIC DEVICES/PRODUCTS.

    Description of Event or Problem · 0

    LITERATURE REVIEWED: ENDOVASCULAR MANAGEMENT OF POST-IRRADIATED CAROTID BLOWOUT SYNDROME IN PATIENTS WITH LOWER NECK CANCERS MANUFACTURERS: MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. THERE WERE 31 PATIENTS IN THE DECONSTRUCTIVE MANAGEMENT (DE) GROUP WHO WERE TREATED BY EMBOLIZATION WITH MICROCOILS (NESTER COILS OR CONCERTO COILS), AND/OR AN ADHESIVE AGENT. ENDOVASCULAR TREATMENT WAS SUCCESSFULLY PERFORMED IN ALL PATIENTS IN THE STUDY AND ACHIEVED IMMEDIATE HEMOSTASIS. MEDTRONIC DEVICES USED: CONCERTO NYLON DETACHABLE COILS. DEATHS AND CAUSES: IN THE DE GROUP, 26/31 PATIENTS (84%) DIED, INCLUDING TWO PATIENTS WHO DIED OF MASSIVE BLEEDING AND 16 PATIENTS WHO DIED OF DISEASE PROGRESSION; THE REMAINING EIGHT PATIENTS DIED OF POOR CLINICAL CONDITION. ADVERSE EVENTS AND CLINICAL OUTCOMES:      ¿ THERE WERE 10 TOTAL CASES OF REBLEEDING IN THE DE GROUP. IT WAS NOTED THAT 3 WERE BLEEDING FROM TREATED VESSELS, 3 WERE BLEEDING FROM OTHER VESSELS, 2 WERE TUMOR BLEEDING, AND 2 REQUIRED NO INTERVENTION.      ¿ THERE WERE 5 CASES OF PERI-PROCEDURAL NEUROLOGICAL COMPLICATIONS IN THE DE GROUP, DEFINED AS WITHIN 3 DAYS OF THE PROCEDURE. THESE WERE ALL DUE TO INFARCTION/STROKE, AND INCLUDED 2 CASES OR HEMIPARESIS AND 1 CASE OF BLURRED VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105999 CONCERTO DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-CONCERTO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Life Threatening| R SEE H11.