BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-90 THERASPHERE (3 GBQ) CANADA COMM

    MDR report key: 12084786 · Received June 29, 2021

    Report

    Report Number
    2134265-2021-08224
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    July 1, 2014
    Report Date
    June 29, 2021
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PADIA, SIDDHARTH A., ET AL. YTTRIUM90 RADIATION SEGMENTECTOMY FOR HEPATIC METASTASES: A MULTI-INSTITUTIONAL STUDY OF SAFETY AND EFFICACY. JOURNAL OF SURGICAL ONCOLOGY, VOL. 123, NO. 1, 2020, PP. 172,178., DOI:10.1002/JSO.26223. DATE OF EVENT: PATIENT TREATMENTS OCCURRED FROM 2013 TO 2018.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT PATIENT COMPLICATIONS OCCURRED. THIS STUDY ASSESSED THE OUTCOMES OF YTTRIUM90 (90Y) RADIATION SEGMENTECTOMY FOR HEPATIC METASTASES UNAMENABLE TO RESECTION OR ABLATION. OVER 6 YEARS, 36 PATIENTS WITH 53 TUMORS UNDERWENT SEGMENTAL RADIOEMBOLIZATION. THERASPHERE WAS A DEVICE REFERENCED WITHIN THE STUDY. THE MOST COMMON COMPLICATION WAS FATIGUE (19%), FOLLOWED BY POSTEMBOLIZATION SYNDROME (17%), CONSISTING OF FATIGUE, FEVERS, AND CHILLS. NO HOSPITALIZATIONS RESULTED FROM THIS. TWO PATIENTS ALSO SUSTAINED LIVER ABSCESSES IN THE TREATMENT REGION, WHICH REQUIRED HOSPITALIZATION AND PERCUTANEOUS DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985301 Y-90 THERASPHERE (3 GBQ) CANADA COMM MICROSPHERES RADIONUCLIDE NAW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention