BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 3799667 · Received April 24, 2014

    Report

    Report Number
    3002124545-2014-00005
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 23, 2014
    Manufacturer
    BIOCOMPATIBLES U.K. LIMITED
    Product Code
    KRD
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT SUBMITTED BY THE TREATING PHYSICIAN, THE PATIENT'S ASCITES AND EDEMA WERE RELATED TO HIS UNDERLYING LIVER DISEASE AND WERE POSSIBLY RELATED TO THE RADIOEMBOLIZATION. THE COMPLICATIONS WERE NOT RELATED TO THE STUDY INTERVENTION (POST RADIOEMBOLIZATION PET AND SPECT IMAGING). THE BTG/ BIOCOMPATIBLES COMPANY PHYSICIAN HAS ASSESSED THIS EVENT AS MEDICALLY REPORTABLE FOR THERASPHERE.

    Description of Event or Problem · 1

    THE PATIENT IS A (B)(6) Y/O M WITH A HISTORY OF HCC WHO SUCCESSFULLY UNDERWENT RADIOEMBOLIZATION (WITH THERASPHERE) TO THE RIGHT HEPATIC LOBE ON (B)(6) 2014. SEVERAL DAYS POST PROCEDURE, THE PATIENT PRESENTED WITH INCREASING ABDOMINAL ASCITES AND NEW ONSET LOWER EXTREMITY EDEMA. HE WAS ADMITTED AND UNDERWENT A PARACENTESIS, AND AFTER CONSULTATION WITH THE LIVER TRANSPLANT TEAM, WAS STARTED ON A DIURETIC, AND THEN DISCHARGED HOME THE NEXT DAY. BOTH THE SERVICE AND THE LIVER TRANSPLANT TEAM AT THE HOSPITAL WILL F/U FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247823 THERASPHERE YTTRIUM-90 MICROSPHERES KRD BIOCOMPATIBLES U.K. LIMITED 4990049

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R GLYCOLAX 17 GRAM/DOSE POWDER| -VERSED 2 MG| LIDOCAINE 1% 10 ML SQ| NADOLOL (CORGARD) 40 MG TABLET| FENTANYL 100 MCG