BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROFRAME-18-AV

    MDR report key: 24010471 · Received January 8, 2026

    Report

    Report Number
    2032493-2026-00006
    Event Type
    Injury
    Date Received
    January 8, 2026
    Date of Event
    December 26, 2025
    Report Date
    February 27, 2026
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    04987350988454
    PMA / PMN Number
    K132952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE RETURNED COIL SYSTEM FOUND THE IMPLANT STRETCHED AND BROKEN AT THE PROXIMAL SECTION AND SEPARATED FROM THE PUSHER. THE INVESTIGATION FOUND THE PUSHER¿S ATTACHMENT MONOFILAMENT WITH A TENSILE BREAK SHAPE AT THE TIP WHICH IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCE THAT EXCEEDED THE STRENGTH OF THE MONOFILAMENT CAUSING THE IMPLANT TO SEPARATE FROM THE PUSHER. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE STRETCHED AND BROKEN IMPLANT, BUT THE DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES EXCEEDING THE IMPLANT'S YIELD AND TENSILE STRENGTH. THE MICROCATHETER USED IN THE PROCEDURE WAS NOT RETURNED FOR EVALUATION, SO THE INVESTIGATION COULD NOT DETERMINE IF IT HAD CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THE REPORTED PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED AT THIS TIME. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL SUBMIT A SUPPLEMENTAL MDR REPORT. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES PREMATURE COIL DETACHMENT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    SEE H11 FOR EVALUATION CONCLUSION.

    Description of Event or Problem · 0

    AS REPORTED, IMPLANT WAS EARLY DETACHED / IMPLANT STRETCHED: THE HYDRO FRAME COIL WAS USED AS THE THIRD COIL DURING THE FRAMING PROCESS. HOWEVER, WHEN THE IMPLANT WAS TAKING SHAPE, RESISTANCE WAS FELT. WHEN THE COIL WAS ATTEMPTED TO BE PULLED TO TAKE SHAPE AGAIN, THE IMPLANT WAS UNINTENTIONALLY DETACHED. THE IMPLANT WAS RETRIEVED USING AN EN SNARE (MERIT MEDICAL) AND SUCCESSFULLY REMOVED FROM THE PATIENT. DURING THE RETRIEVAL PROCESS, IT WAS FOUND THAT THE PROXIMAL SIDE OF THE IMPLANT HAD BEEN STRETCHED. THE COIL WAS NOT USED AND WAS REPLACED WITH ANOTHER COIL TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71994 HYDROFRAME-18-AV DEVICE VASCULAR FOR PROMOTING EMBOLIZATION KRD MICROVENTION, INC. MV-81036HHFA 0000719189 04987350988454

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention