BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELIMINATE PLUS

    MDR report key: 23309507 · Received October 16, 2025

    Report

    Report Number
    3009500972-2025-00014
    Event Type
    Injury
    Date Received
    October 16, 2025
    Report Date
    October 16, 2025
    Manufacturer
    TERUMO CLINICAL SUPPLY CO., LTD.
    Product Code
    QEZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED A2: AGE OR DATE OF BIRTH: REQUESTED, NOT PROVIDED A3A: SEX: REQUESTED, NOT PROVIDED A4: WEIGHT: REQUESTED, NOT PROVIDED A5: ETHNICITY: REQUESTED, NOT PROVIDED A6: RACE: REQUESTED, NOT PROVIDED B3: DATE OF EVENT: REQUESTED, NOT PROVIDED D4: LOT NUMBER: REQUESTED, UNKNOWN D4: EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED E1: INITIAL REPORTER NAME: REQUESTED, NOT PROVIDED G4: 510K: N/A H4: DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER INVESTIGATION RESULT: VISUAL INSPECTION - SINCE THE INVOLVED DEVICE WAS NOT RETURNED, IT WAS IMPOSSIBLE TO ANALYZE. INVESTIGATION OF PAST COMPLAINTS: AN INVESTIGATION WAS CONDUCTED INTO PAST COMPLAINTS OF A SIMILAR NATURE. AS A RESULT, NO SIMILAR COMPLAINTS HAVE OCCURRED SINCE (B)(6) 2022. INSPECTION OF TREND ABNORMALITIES: WE INSPECTED TREND ABNORMALITIES FOR THIS PRODUCT AND FOUND NO PAST OCCURRENCES OR PATTERNS INDICATING A RISK OF STENT DEFORMATION DURING ASPIRATION. PRESUMED CAUSE: SINCE THE INVOLVED DEVICE WAS NOT RETURNED AND NO ABNORMALITIES WERE FOUND IN THE INVESTIGATION, WE COULD NOT IDENTIFY THE CAUSE OF THE STENT DEFORMATION THAT OCCURRED DURING ASPIRATION. NO ABNORMALITIES WERE FOUND THAT COULD POTENTIALLY LEAD TO DEFORMATION OF AN IMPLANTED STENT DURING ASPIRATION USING THE DEVICE. (B)(4) (IMPORTER), REGISTRATION NO. (B)(4), IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO CLINICAL SUPPLY CO., LTD. (MANUFACTURER), REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. A THROMBUS WAS PRESENT INSIDE THE LUMEN OF THE STENT PLACED WITHIN THE BLOOD VESSEL, SO ASPIRATION WAS ATTEMPTED USING THE DEVICE IN QUESTION. WHEN THE THROMBUS INSIDE THE STENT LUMEN WAS ASPIRATED USING THE DEVICE, THE STENT DEFORMED IN RESPONSE TO THE MOVEMENT OF THE DEVICE. SUBSEQUENT CONFIRMATION WITH IVUS REVEALED THAT THE STENT HAD BECOME COMPLETELY FLATTENED. THEREFORE, A GUIDEWIRE WAS PASSED THROUGH THE STENT, AND THE FLATTENED STENT WAS EXPANDED USING A BALLOON AND PRESSED AGAINST THE VESSEL WALL. INTERVENTION WAS REQUIRED TO PREVENT PERMANENT IMPAIRMENT/DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2743359 ELIMINATE PLUS ASPIRATION CATHETER QEZ TERUMO CLINICAL SUPPLY CO., LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention