BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 4366453 · Received December 18, 2014

    Report

    Report Number
    3002124545-2014-00038
    Event Type
    Death
    Date Received
    December 18, 2014
    Date of Event
    November 26, 2014
    Report Date
    December 17, 2014
    Manufacturer
    BIOCOMPATIBLES U.K. LIMITED
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, PT UNDERWENT SELECTIVE INTERNAL RADIATION THERAPY (SIRT) WITH Y90 LOADED THERASPHERES. A BREMSSTRAHLUNG SCAN WAS OBTAINED, PT TRANSFERRED TO RECOVERY AND DISCHARGE 6 HOURS LATER WITHOUT COMPLICATIONS. ON (B)(6) 2014, INTERVENTIONAL RADIOLOGY NURSE POSTOPERATIVE FOLLOW-UP CALL. NURSE SPOKE WITH DAUGHTER (PT WAS SLEEPING. NO REAL COMPLAINTS; JUST TIRED. REASSURED THIS WAS NORMAL, ADVISED TO CONTINUE HYDRATION, REST, AND PRESCRIPTION, AS NEEDED. ON (B)(6) 2014, INTERVENTIONAL RADIOLOGY NURSE POSTOPERATIVE FOLLOW-UP CALL. NURSE SPOKE WITH DAUGHTER WHO RELAYED THAT ON (B)(6) 2014, PT HAD FALLEN AND WHEN LIFTED UP, EYES ROLLED BACK IN HEAD AND HE EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832860 THERASPHERE YTTRIUM-90 MICROSPHERES NAW BIOCOMPATIBLES U.K. LIMITED 4990248

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death