BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR VUE HYDROGEL

    MDR report key: 16683818 · Received April 4, 2023

    Report

    Report Number
    MW5116341
    Event Type
    Injury
    Date Received
    April 4, 2023
    Date of Event
    June 22, 2022
    Report Date
    April 2, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DESCRIBE EVENT, PROBLEM, OR PRODUCT USE ERROR: THE PATIENT UNDERWENT SPACEOAR INJECTION ((B)(6) 2022) IN THE PERIRECTAL SPACE PRIOR TO RADIATION TO THE PROSTATE THAT WAS COMPLETED ON (B)(6), 2022. THE SPACEOAR INJECTION WAS UNEVENTFUL. HE PRESENTED WITH PROCTITIS AND A LARGE CAVITARY RECTAL ULCERATION IN (B)(6) 2022. WHILE HIS EVALUATION IS ONGOING, HE IS SUSPECTED TO HAVE A RECTO-UREHTRAL OR RECTOPROSTATIC FISTULA DUE TO THE PRESENCE OF RECURRENT URINARY TRACT INFECTIONS. IN THE ABSENCE OF USING SPACEOAR, RECTOURETHRAL FISTULAS AND LARGE CAVITARY ULCERATIONS OF THE RECTUM ARE EXTREMELY RARE EVENTS WHEN TREATING PROSTATE CANCER. SPACE OAR IS SUPPOSE TO LOWER THE RISK OF MILD TO MODERATE SIDE EFFECTS TO THE RECTUM, BUT IN THIS CASE IT IS SUSPECTED TO HAVE CAUSED A MAJOR (GRADE 4 OUT OF 5) SIDE EFFECT. MY PRACTICE OF 7 PHYSICIANS HAS NOW SEEN 2 CASES OF RECTOURETHRAL FISTULAS SECONDARY TO SPACE OAR IN THE LAST 12 MONTHS. THIS WAS A NEVER BEFORE SEEN COMPLICATION OF RADIATION THERAPY TO THE PROSTATE FOR OUR COMMUNITY PRIOR TO THESE EVENTS. THIS COMPLICATION IS LIFE ALTERING AND MAY REQUIRE URINARY AND BOWEL DIVERSIONS WITH POSSIBLE RECONSTRUCTIVE SURGERY OR SURGERIES. THE RISK OF MULTIPLE HOSPITALIZATIONS IS HIGH. CT ABDOMEN/PELVIS IN (B)(6) 2022 SHOWED RECTAL WALL THICKENING WITH FINDINGS WORRISOME FOR LOCALIZED PERFORATION OR FISTULA OF THE RECTUM POSTERIOR TO THE PROSTATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416086 SPACEOAR VUE HYDROGEL HYDROGEL SPACER OVB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Disability| O| L| H| R RADIATION THERAPY.