BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 18406655 · Received December 27, 2023

    Report

    Report Number
    2124215-2023-71125
    Event Type
    Malfunction
    Date Received
    December 27, 2023
    Date of Event
    February 25, 2023
    Report Date
    December 27, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K181465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, 02/25/2023, WAS CHOSEN AS THE BEST ESTIMATE BASED ON DATE THE ARTICLE WAS ACCEPTED TO PUBLISHED. BLOCKS D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE HOULIHAN, OA ET AL. A RANDOMIZED FEASIBILITY TRIAL OF STEREOTACTIC PROSTATE RADIATION THERAPY WITH OR WITHOUT ELECTIVE NODAL IRRADIATION IN HIGH-RISK LOCALIZED PROSTATE CANCER (SPORT TRIAL). INT J RADIAT ONCOL BIOL PHYS (2023); 117(3): 594-609. BLOCK H6: IMDRF DEVICE CODE A1502 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF GEL MISPLACED-NON VASCULAR.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF THE EVENT INVOLVING AN SPACEOAR HYDROGEL SYSTEM, THROUGH THE ARTICLE "A RANDOMIZED FEASIBILITY TRIAL OF STEREOTACTIC PROSTATE RADIATION THERAPY WITH OR WITHOUT ELECTIVE NODAL IRRADIATION IN HIGH RISK LOCALIZED PROSTATE CANCER WRITTEN BY ORLA A HOULIHAN, MB BCH ET AL." PER THE ARTICLE, BETWEEN (B)(6) 2016 AND (B)(6) 2018, 51 PATIENTS WERE GIVEN PATIENT INFORMATION SHEETS FOR THE STUDY OF THESE 31 PATIENTS WERE RANDOMIZED. THE PATIENTS UNDERWENT A SPACEOAR HYDROGEL INJECTION, THREE FIDUCIAL MARKERS WERE PLACED TRANSPERINEALLY. THE PATIENTS WERE TREATED EITHER WITH SABR OR PROSTATE PLUS PELVIC LYMPH NODES (PN-SABR). PATIENTS THAT WERE TREATED WITH P-SABR RECEIVED 36.25 GY IN 5 FRACTIONS FOR 29 DAYS AND THE ONES TREATED WITH PPN-SABR RECEIVED 25 GY/5 FRACTIONS, THE TOXICITY INFORMATION WAS COLLECTED WEEKLY AT EACH TREATMENT AND AT 6 WEEKS AND 3 MONTHS. THE PATIENTS DEVELOPED NON SERIOUS LATE TOXICITY DUE TO THE RADIATION EFFECTS. THIS EVENT WAS CREATED TO REPORT THE PATIENT THAT WAS EXCLUDED BEFORE THE SABR, DUE TO THE INFILTRATION IN THE RECTAL WALL OF THE HYDROGEL. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273904 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SO-1010

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male