BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEOAR VUE SYSTEM

    MDR report key: 11827641 · Received May 14, 2021

    Report

    Report Number
    3005099803-2021-02173
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 1, 2021
    Report Date
    May 14, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K182971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, (B)(6) 2021, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT, (B)(4) 2021. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPACEOAR VUE WAS IMPLANTED DURING A SPACEOAR VUE PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. FIDUCIALS WERE ADMINISTERED TRANSPERINEALLY PRIOR TO SPACEOAR VUE IMPLANTATION AND THE PROCEDURE WAS DONE UNDER LOCAL ANESTHESIA. COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED POST SPACEOAR PROCEDURE AND THE GEL APPEARED TO BE IN THE ANTERIOR, POSSIBLY WITHIN THE PROSTATE CAPSULE. IT WAS UNKNOWN IF THE PATIENT HAS EXTRACAPSULAR EXTENSION(ECE) AS HE DID NOT GET A DIAGNOSTIC MAGNETIC RESONANCE IMAGING (MRI). THE PHYSICIAN BELIEVED THAT THE GEL COULD HAVE BEEN TAKEN UP INTO THE PROSTATE THROUGH EXTRACAPSULAR EXTENSION (ECE) THUS CAUSING LATERAL/ANTERIOR GEL INFILTRATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WILL RECEIVE EXTERNAL BEAM RADIATION THERAPY (EBRT) WITH TO DO 43 FRACTIONS INSTEAD OF 22.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724988 SPACEOAR VUE SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SV-2101

    Patients

    Seq Age Sex Outcome Treatment
    1