BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 2802931 · Received October 19, 2012

    Report

    Report Number
    8022247-2012-00013
    Event Type
    Death
    Date Received
    October 19, 2012
    Date of Event
    September 10, 2012
    Report Date
    October 19, 2012
    Manufacturer
    NORDION (CANADA) INC.
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS SERIOUS AND UNEXPECTED DUE TO THE DEATH OF A PATIENT LESS THAN 2 MONTHS AFTER THERASPHERE TREATMENT. HOWEVER, THE TREATING PHYSICIAN HAS INDICATED THAT HE FEELS THE EVENT TO BE PROBABLY NOT RELATED TO THERASPHERE. THE (B)(6) PHYSICIAN FEELS THAT THE BILATERAL LE EDEMA, RLE DVT AND SOB SEEM UNRELATED TO THERASPHERE TREATMENT BUT THE ASCITES AND PARACENTESIS ARE MOST LIKELY LIVER RELATED. ALTHOUGH THIS DEATH IS PROBABLY NOT RELATED TO THERASPHERE, UNABLE TO RULE OUT THE POSSIBILITY THAT THE TREATMENT CONTRIBUTED TO HIS WORSENING CONDITION AND DEATH.

    Description of Event or Problem · 1

    DEATH OF A PATIENT ENROLLED IN A (B)(4) STUDY. THE PATIENT HAD ADENOCARCINOMA WITH METS TO LIVER AND A TUMOR VOLUME OF 60%. HE WAS TREATED WITH THERASPHERE ON (B)(6) 2012, WITH 112.4 GY TO THE RIGHT HEPATIC LOBE AND ON (B)(6), HIS WIFE CALLED TO REPORT THAT HE HAD DEVELOPED SIGNIFICANT BILATERAL LE EDEMA, ON (B)(6), SHE REPORTED THAT HE HAD BEEN RECEIVING LASIX AND OXYGEN FOR 2 DAYS BUT WAS STILL EXPERIENCING SHORTNESS OF BREATH. SHE LATER REPORTED THAT HE HAD BEEN DIAGNOSED WITH A RLE DVT AND WAS PUT ON COUMADIN. ON (B)(6), THE PATIENT WAS ADMITTED TO HOSPITAL FOR ASCITES AND PARACENTESIS. HE WAS ADMITTED TO HOSPITAL AGAIN ON (B)(6) AND WAS ANEMIC, HIS LFTS WERE MARKEDLY ELEVATED, AND HIS BICARB WAS 12.9. TRANSFERRED TO ICU ON (B)(6) AND DEVELOPED INCREASED SHORTNESS OF BREATH AND ELECTROLYTES WERE MORE ABNORMAL AND SUSTAINED LOW EFFICIENCY DIALYSIS WAS STARTED. HE CONTINUED TO DECOMPENSATE, BECOMING HYPOTENSIVE AND DIED ON (B)(6).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death| H FLOURACIL| RECEIVE ALTERNATIVE THERAPY WITH LAETRILE| DOCETAXEL| OXALIPLATIN| OTHER HOLISTIC ALTERNATIVES UNTIL (B)(6) 2012| PATIENT ELECTED TO STOP SYSTEMIC THERAPY AND| DMSO (DIMETHYL SULFOXID)