BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 8721159 · Received June 21, 2019

    Report

    Report Number
    3002124543-2019-00050
    Event Type
    Injury
    Date Received
    June 21, 2019
    Date of Event
    May 13, 2018
    Report Date
    May 22, 2019
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENTS WERE REPORTED THROUGH A RETROSPECTIVE CLINICAL TRIAL. THE EVENTS ARE CONSIDERED SERIOUS AND POSSIBLY RELATED TO THERASPHERE (REPORTING INVESTIGATOR), POSSIBLY RELATED TO PATIENT CONDITION (BTG MEDICAL ASSESSMENT). BTG MEDICAL ASSESSMENT: ASCITES OCCURRED 8 MONTHS AFTER THERASPHERE® ADMINISTRATION. ASCITES IS A CONSEQUENCE OF LIVER DYSFUNCTION CAUSE BY THE CIRRHOSIS NOT BY THE DEVICE. SEVERITY GRADE 3; SERIOUS; NOT RELATED; EXPECTED. ASCITES IS AN ANTICIPATED ADVERSE EVENT AS PER THE IFU/RISK MANAGEMENT DOCUMENTATION. THERE WAS A DIFFERENCE OF OPINION WITH REGARDS TO THE CAUSALITY OF THIS EVENT - AS FOLLOWS: INVESTIGATING PHYSICIAN CONCLUSION: SERIOUS LED TO HOSPITALIZATION. POSSIBLY RELATED TO THERASPHERE DEVICE. "I THINK THAT Y90 CAN LEAD TO LIVER FIBROSIS WHICH CAN LEAD TO PORTAL HYPERTENSION WITH RESULTANT ASCITES. THE ASCITES IS POSSIBLY RELATED TO THE Y90 IN MY VIEW." BTG MEDICAL CONCLUSION: SERIOUS - NOT RELATED TO THERASPHERE DEVICE. "8 MOTHS IS NOT SUFFICIENT TO CREATE A CIRRHOSIS SEVERE ENOUGH TO LEAD TO ASCITES." THEREFORE, WE ARE REPORTING THIS EVENT WITH AN ABUNDANCE OF CAUTION. NO DEVICE MALFUNCTION WAS REPORTED AND NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN HAS BEEN IDENTIFIED. THE LOT NUMBER ASSOCIATED WITH THE THERASPHERE ADMINISTRATION WAS NOT REPORTED, THEREFORE NO INVESTIGATION COULD BE PERFORMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. NO OTHER INFORMATION IS AVAILABLE THAT COULD CONFIRM/DENY THE ALLEGED EVENT. AT THIS TIME, THIS REPORT IS CONSIDERED FINAL.

    Description of Event or Problem · 1

    AUTO-NOTIFICATION RECEIVED FROM (B)(4), 22-MAY-2019. A PATIENT HAS REPORTED A SERIOUS ADVERSE EVENT. SITE NUMBER: (B)(4); UNIQUE PATIENT ID: (B)(6); DIAGNOSTIC TERM TO DESCRIBE PRIMARY SAE: ASCITES; SERIOUS CRITERIA: LED TO A SERIOUS INJURY THAT REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION; START DATE (DD-MMM-YYYY): (B)(6) 2018; SAE OUTCOME: NOT RESOLVED; SEVERITY-CTCAE V5.0 GRADE: GRADE 3. 1ST THERASPHERE TREATMENT DATE: (B)(6) 2017, LUNG SHUNT FRACTION: 2%. 2ND THERASPHERE TREATMENT DATE: (B)(6) 2017, LUNG SHUNT FRACTION: 2%, TOTAL ADMINISTERED ACTIVITY: 1.36GBQ. REPORTING PHYSICIAN ASSESSMENT: CAUSALITY RELATED TO PROCEDURE: UNRELATED. CAUSALITY RELATED TO THERASPHERE DEVICE: POSSIBLY RELATED. (B)(6) YEAR OLD FEMALE WAS ADMITTED THROUGH AN OUTSIDE ED ON (B)(6) 2018 AND HAD 6L REMOVED VIA PARACENTESIS. SHE WAS DISCHARGED (B)(6) 2018. EVENT WAS UNRESOLVED AT TIME THAT END OF STUDY CRITERIA WAS MET (TRANSPLANTED (B)(6) 2018). LIMITED INFORMATION DUE TO OUTSIDE FACILITY TREATMENT. SITE ATTRIBUTES SAE AS POSSIBLY RELATED TO 2ND TS TREATMENT (DEVICE). UPDATE 18JUNE2019: DUE TO TIME LAPSE BETWEEN 2ND TREATMENT AND EVENT (8 MONTHS), THE RELATEDNESS TO THERASPHERE DEVICE WAS QUERIED WITH THE INVESTIGATOR. DETERMINATION REMAINS "POSSIBLY RELATED TO THERASPHERE" AS CONFIRMED WITH INVESTIGATING PHYSICIAN. THE EVENTS WERE NOT REPORTED TO BTG BY THE INVESTIGATOR IN 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516958 THERASPHERE YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW NAW BIOCOMPATIBLES UK LTD UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R