BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 9238695 · Received October 25, 2019

    Report

    Report Number
    3002124543-2019-00062
    Event Type
    Injury
    Date Received
    October 25, 2019
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BTG MEDICAL ASSESSMENT: ON THE (B)(6) 2019, PATIENT WAS TREATED WITH 1.79GBQ OF THERASPHERE ADMINISTERED IN THE LEFT LIVER VIA FEMORAL ARTERY. PATIENT WAS HOSPITALISED FOR DIGESTIVE HEMORRHAGE (START (B)(6) 2019, STOP (B)(6) 2019) AND HAS BEEN TREATED BY SANDOSTATINE, PROPHYLACTIC ANTIBIOTHERAPY AND ELASTIC ON OESOPHAGUS VARICES. INVESTIGATOR LISTED CAUSALITY OF THE SAE AS CONCURRENT DISEASE AND CONFIRMED THE EVENT NOT TO BE RELATED TO THE ADMINISTRATION PROCEDURE OR THERASPHERE® DEVICE ACTION TAKEN: SURGERY OR INTERVENTIONAL RADIOLOGY PROCEDURE AND CONCOMITANT MEDICATION. AT BASELINE PATIENT IS TO BE CLASSIFIED BCLC C, MULTIFOCAL TUMOR AND ALTERATION OF LIVER FUNCTION. THE EVENT OCCURRED 5 WEEKS AFTER THERASPHERE ADMINISTRATION IN A PATIENT THAT HAS LIVER CIRRHOSIS. IT IS LIKELY THAT THERASPHERE TREATMENT HAS LED TO THE INCREASE OF PREEXISTING PORTAL HYPERTENSION, AND CAUSED THE UPPER GI HEMORRHAGE IT IS OF NOTE THAT THE PATIENT RECEIVED A TREATMENT EVEN THE PRESENCE OF "WARNING", CHILD B8, ELEVATED BILIRUBIN, THIS PATIENT WAS AT HIGH RISK OF DISEASE DECOMPENSATION. HEMORRHAGE IS AN ANTICIPATED ADVERSE EVENT LISTED IN THE STUDY PROTOCOL/RISK MANAGEMENT DOCUMENTATION. SEVERITY GRADE 4; SERIOUS: YES, PATIENT WAS HOSPITALISED; ANTICIPATED; RELATED: DEVICE POSSIBLY INCREASED PRE EXISTING PORTAL HYPERTENSION. 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 DATATRAK SITE # (B)(4), SUBJECT NUMBER: 250015-002, (B)(6) 2019. SUBJECT NUMBER: 250015-002 MALE PATIENT BORN IN 1956, (B)(6). MAIN COMORBIDITIES; ALCOHOL INTAKE HISTORY AND TOBACCO INTAKE HISTORY. DISEASE CHARACTERISTICS: LIVER CIRRHOSIS RELATED TO ALCOHOL. TUMOUR TYPE: HCC DIAGNOSED (B)(6) 2017, MULTIFOCAL TUMOUR IN THE RIGHT AND LEFT LIVER. PATIENT HAS RECEIVED PRIOR ANTI-CANCER TREATMENTS, LOCO REGIONAL LIVER TREATMENT AND LIVER SURGERY. THE LOCO REGIONAL LIVER TREATMENT HAS BEEN LISTED AS ABLATION: NOT DOCUMENT I IF IT WAS RFA, MICROWAVE, OR CRYO. THE PATIENT REQUIRED LIVER RESECTION AND THE LIVER SEGMENT THAT WAS REMOVED. PRE TREATMENT BIOLOGY: BILIRUBIN 44 MICRO MOL/L, ALBUMIN 27GR/L, ASL 3XULN CHILD PUGH SCORE B8, BCLCC AND ECOG NOT MEASURED, ON THE (B)(6) 2019, PATIENT WAS TREATED WITH 1.79GBQ OF THERASPHERE ADMINISTERED IN THE LEFT LIVER VIA FEMORAL ARTERY. PATIENT WAS HOSPITALISED FOR DIGESTIVE HEMORRHAGE (START (B)(6) 2019, STOP (B)(6) 2019) AND HAS BEEN TREATED BY SANDOSTATINE, PROPHYLACTIC ANTIBIOTHERAPY AND ELASTIC ON OESOPHAGUS VARICES. INVESTIGATOR LISTED CAUSALITY OF THE SAE AS CONCURRENT DISEASE AND CONFIRMED THE EVENT NOT TO BE RELATED TO THE ADMINISTRATION PROCEDURE OR THERASPHERE® DEVICE ACTION TAKEN: SURGERY OR INTERVENTIONAL RADIOLOGY PROCEDURE AND CONCOMITANT MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034716 THERASPHERE YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW NAW BIOCOMPATIBLES UK LTD 1.79GBQ UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization