BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYDROSOFT 3D

    MDR report key: 12029245 · Received June 18, 2021

    Report

    Report Number
    2032493-2021-00230
    Event Type
    Death
    Date Received
    June 18, 2021
    Date of Event
    May 17, 2021
    Report Date
    May 19, 2021
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    UDI-DI
    00816777026521
    PMA / PMN Number
    K080666
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE PUSHER OF THE DEVICE WAS RETURNED FOR EVALUATION AND THE ATTACHMENT MONOFILAMENT PROFILE HAD A MUSHROOM SHAPE, INDICATING THAT A THERMAL DETACHMENT HAD OCCURRED DURING THE PROCEDURE. THERE WAS NO FAULT TO THE CIRCUITRY OF THE PUSHER, AS IT HAD PASSED RESISTANCE AND CONTINUITY TESTING, AND NO SHORT CONDITION WAS PRESENT. THE PUSHER WAS DAMAGED IN MULTIPLE LOCATION ALONG ITS LENGTH. THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE DAMAGE FOUND ON THE PUSHER COULD NOT BE IDENTIFIED, BUT THE DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES OVER SPECIFICATION. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES PREMATURE COIL DETACHMENT AND DEATH AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MV COILS WERE UTILIZED TO TREAT A SERIOUSLY ILL PATIENT WITH A RUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY. AFTER SUCCESSFUL PLACEMENT OF FOUR COILS, THE SURGEON REPORTED DIFFICULTY IN REPOSITIONING OF THE 5TH EMBOLIZATION COIL. THE COIL APPARENTLY DETACHED DURING REPOSITIONING, COULD NOT BE REMOVED, AND APPROXIMATELY 4CM OF THE COIL WAS LEFT IN THE ICA AND A1 SEGMENT OF THE ACA. A STENT WAS PLACED TO AFFIX THE COIL TO THE WALLS OF THE VESSEL. THE PATIENT WAS REPORTED TO HAVE PASSED AWAY THE FOLLOWING DAY AS A RESULT OF A RE-BLEED OF THE ANEURYSM. THE NEUROSURGERY TEAM CONSIDERED THE SURGERY EXTREMELY HIGH RISK GIVEN THE PATIENT'S PRE-PROCEDURE CONDITION, AND REPORTED THAT THE DEATH WAS NOT DUE TO THE CHALLENGES ENCOUNTERED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921098 HYDROSOFT 3D NEUROVASCULAR EMBOLIZATION DEVICE HCG MICROVENTION, INC. 100208HFRM-V-3D-A2 2012085W6 00816777026521

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R