BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LC BEAD

    MDR report key: 12143519 · Received July 9, 2021

    Report

    Report Number
    2134265-2021-08694
    Event Type
    Injury
    Date Received
    July 9, 2021
    Date of Event
    February 1, 2016
    Report Date
    July 9, 2021
    Manufacturer
    BTG FARNHAM
    Product Code
    HCG
    PMA / PMN Number
    K083091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: TRUE EVENT DATE IS UNKNOWN. EVENT DATE IS ESTIMATED TO THE FIRST MONTH OF THE CLINICAL STUDY (B)(6) 2016. IMPLANT DATE: BETWEEN (B)(6) 2016 - (B)(6) 2017. APA CITATION: LAKHOO, J., ADAMS, R., DAVE, A., LUO, L., VARGO, C. J., ISAACSON, A. J., SHER, A., FISCHMAN, A., YEE, D. C., RYAN, S., PATEL, S., DUCHAC, D., & BROWN, D. B. (2020). RADIOPAQUE BEADS LOADED WITH DOXORUBICIN IN THE TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA: A RETROSPECTIVE, MULTI-CENTER STUDY. CANCER TREATMENT AND RESEARCH COMMUNICATIONS, 25, 100208. HTTPS://DOI.ORG/10.1016/J.CTARC.2020.100208.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A RETROSPECTIVE, MULTI-CENTER STUDY "RADIOPAQUE BEADS LOADED WITH DOXORUBICIN IN THE TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA" THAT PATIENTS EXPERIENCED FATIGUE, ABDOMINAL PAIN AND TOXICITY. THE PRIMARY OBJECTIVE OF THIS STUDY WAS TO EVALUATE OVERALL DISEASE AND TARGET TUMOR RESPONSE OF NON-RESECTABLE HEPATOCELLULAR CARCINOMA (HCC) AFTER TRANSARTERIAL CHEMOEMBOLIZATION (TACE) WITH A DOXORUBICIN-LOADED RADIOPAQUE MICROSPHERE. DATA AS ABSTRACTED FROM RECORDS OF PATIENTS WITH UNRESECTABLE HCC WHO RECEIVED TACE WITH DOXORUBICIN LOADED RADIOPAQUE LC BEAD LUMI MICROSPHERES AT ONE OF FIVE UNITED STATES CENTERS BETWEEN FEBRUARY 2016 - NOVEMBER 2017. 82 PATIENTS UNDERWENT 130 TREATMENTS. MOST PATIENTS, HOWEVER, RECEIVED ONLY ONE (45/82) OR TWO TREATMENTS (29/82). FIVE PATIENTS EXPERIENCED ADVERSE EVENTS OF FATIGUE, ABDOMINAL PAIN AND TOXICITY. NO GRADE 4-5 TOXICITIES OCCURRED. NO TREATMENT INFORMATION WAS SUPPLIED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037518 LC BEAD HCG BTG FARNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other