BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 3642283 · Received February 5, 2014

    Report

    Report Number
    8022247-2014-00001
    Event Type
    Death
    Date Received
    February 5, 2014
    Date of Event
    December 18, 2013
    Report Date
    February 5, 2014
    Manufacturer
    NORDION (CANADA) INC
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    GIVEN THE FACT THAT THE EVENT WAS FATAL AND GIVEN THE TIME-FRAME IN WHICH IT OCCURRED RELATIVE TO THERASPHERE ADMINISTRATION THIS EVENT IS MEDICALLY REPORTABLE. IT MAY BE IMPOSSIBLE TO DETERMINE CAUSALITY GIVEN THE PATIENT'S PRE-EXISTING MEDICAL CONDITIONS AND AGE IN THE ABSENCE OF AN AUTOPSY.

    Description of Event or Problem · 1

    A PT WITH A CLINICAL HISTORY OF MULTIFOCAL HCC WAS TREATED WITH THERASPHERE ON (B)(6) 2013 WITH NO COMPLICATIONS. ON (B)(6) 2013 THE PT PRESENTED TO THE (B)(6) EMERGENCY ROOM AND WAS FOUND TO BE HYPOTENSIVE AND HYPOTOXIC. CARDIOLOGY DIAGNOSED DEMAND ISCHEMIA. ADMITTED TO ICU FOR HYPOVOLEMIC SHOCK, ACUTE RENAL FAILURE AND NON-ST ELEVATION MYOCARDIAL INFARCTION. PT HYDRATED. CT OF ABDOMEN SHOWED NO HEMORRHAGE OR VASCULAR INJURY. PT DISCHARGED TO REHAB (B)(6) 2013. ON (B)(6) 2013 THE PT SHOWED SHORTNESS OF BREATH AT REHAB BUT REFUSED TO GO TO HOSPITAL. PT GRADUALLY BECAME UNRESPONSIVE AND PROGRESSED TO RESPIRATORY ARREST. ARRIVED AT (B)(6) EMERGENCY DEPT WITH CPR IN PROGRESS. EMERGENCY ROOM ACLS PERFORMED. PT PRONOUNCED BY EMERGENCY DEPT PHYSICIAN CARDIAC ARREST/RESPIRATORY ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75959 THERASPHERE YTTRIUM-90 MICROSPHERES NAW NORDION (CANADA) INC

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H