BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYDROFRAME 10 ADVANCED

    MDR report key: 11682815 · Received April 16, 2021

    Report

    Report Number
    2032493-2021-00134
    Event Type
    Death
    Date Received
    April 16, 2021
    Date of Event
    March 9, 2021
    Report Date
    May 18, 2021
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    UDI-DI
    00816777023575
    PMA / PMN Number
    K090357
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISTRIBUTOR CONFIRMED VIA EMAIL CORRESPONDENCE THAT THE ACTUAL DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    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 INVESTIGATION OF THE RETURNED COIL SYSTEM CONFIRMED THE RETURNED PUSHER IS A NON MICROVENTION PRODUCT. THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AS THE MICROVENTION COIL SYSTEM WAS NOT RETURNED. FOUR FLUOROSCOPIC IMAGES WERE PROVIDED. THE FIRST IMAGE SHOWS A PARTIALLY COILED ANEURYSM WITH A SECTION OF A COIL EXTENDING PROXIMALLY IN THE PARENT ARTERY. THE SECOND AND THIRD IMAGES SHOW A STRETCHED SECTION OF THE EMBOLIC COIL EXTENDING INTO THE PARENT ARTERY. THE FOURTH IMAGE IS OF LIMITED QUALITY AND THE ANEURYSM AND EMBOLIC COILS CANNOT BE CLEARLY SEEN. THE FIRST, SECOND AND THIRD IMAGE CONFIRMED THE CONDITION DESCRIBED IN THE COMPLAINT; HOWEVER, THE REVIEW OF THE IMAGES COULD NOT VERIFY IF THE DEVICE SHOWN WAS A MICROVENTION PRODUCT OR THE PRODUCT RETURNED. THEREFORE, THE REPORTED COMPLAINT IS CONSIDERED NON-VERIFIABLE. THE INSTRUCTIONS FOR USE IDENTIFIES COIL MISPLACEMENT AND DEATH AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY, AN EMBOLIZATION COIL STRETCHED AND DETACHED DURING AN ATTEMPT TO RE-FRAME IT. A PORTION OF THE IMPLANT COIL REMAINED IN THE PARENT VESSEL. A STENT WAS PLACED AT THE NECK OF THE ANEURYSM TO AFFIX THE STRETCHED COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CONCERNS ABOUT BLOOD FLOW. THE PATIENT'S CONDITION WAS REPORTED TO HAVE DETERIORATED POST-PROCEDURE AND THE PATIENT PASSED AWAY LATER. THE OFFICIAL CAUSE OF DEATH WAS INTRACRANIAL HEMORRHAGE. IT WAS STATED BY THE TREATING PHYSICIAN THAT THE STRETCHED COIL DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579379 HYDROFRAME 10 ADVANCED NEUROVASCULAR EMBOLIZATION DEVICE HCG MICROVENTION, INC. 100728HFRM-V-A2 1804105YB 00816777023575

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| R