BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 17801422 · Received September 22, 2023

    Report

    Report Number
    3005099803-2023-04962
    Event Type
    Injury
    Date Received
    September 22, 2023
    Date of Event
    June 1, 2021
    Report Date
    September 22, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K181465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 WAS CHOSEN AS THE BEST ESTIMATE BASED ON THE DATE THE ARTICLE WAS RECEIVED, (B)(6) 2021. BLOCKS D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE UPN/LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE MATSUGASUMI, T ET AL. CHALLENGE AND OUTCOME FOR THE PROSTATE SQUAMOUS CELL CARCINOMA WHICH DEVELOPED 8 YEARS AFTER LOW-DOSE-RATE BRACHYTHERAPY APPROACHED BY A COMBINED MULTIMODAL TREATMENT WITH HIGH-DOSE-RATE INTERSTITIAL BRACHYTHERAPY, EXTERNAL BEAM RADIATION THERAPY AND CHEMOTHERAPY. CASE REP ONCOL (2021); 14(2): 854-860. HTTPS://DOI.ORG/10.1159/000516034" BLOCK H6: IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF BLEEDING. IMDRF PATIENT CODE E2330 CAPTURES THE REPORTABLE EVENT OF PAIN. IMDRF PATIENT CODE E2326 CAPTURES THE REPORTABLE EVENT OF INFLAMMATION. IMDRF PATIENT CODE E2314 CAPTURES THE REPORTABLE EVENT OF FISTULA.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING A SPACEOAR DEVICE THROUGH THE ARTICLE "CHALLENGE AND OUTCOME FOR THE PROSTATE SQUAMOUS CELL CARCINOMA WHICH DEVELOPED 8 YEARS AFTER LOW-DOSE-RATE BRACHYTHERAPY APPROACHED BY A COMBINED MULTIMODAL TREATMENT WITH HIGH-DOSE-RATE INTERSTITIAL BRACHYTHERAPY, EXTERNAL BEAM RADIATION THERAPY AND CHEMOTHERAPY" WRITTEN BY MATSUGASUMI, T ET AL. THE ARTICLE DESCRIBES THE CASE OF A PATIENT WHO UNDERWENT A PROSTATE BIOPSY 8 YEARS AGO, HE WAS DIAGNOSED WITH PROSTATE CANCER AND HAD GLEASON SCORE 3+4 AT ONE SITE, OUT OF THE 8 PROSTATE BIOPSIES. THE PROSTATE CANCER WAS TREATED WITH NEOADJUVANT ANDROGEN DEPRIVATION THERAPY FOR SIX MONTHS AND IODINE -125 IMPLANTATION. HE RECEIVED 145 GY; NO BIOCHEMICAL FAILURE WAS REPORTED. EIGHT YEARS LATER, THE PATIENT REPORTED PERSISTENT MICTURITION PAIN. URINARY CYTOLOGY AND CULTURES WERE PERFORMED, ALL NEGATIVE. A CYSTOSCOPY REVELED URETHRAL STENOSIS NEAR THE COLLICULUS SEMINAL IS DUE TO FIBROUS DEPOSITS. MAGNETIC RESONANCE IMAGING (MRI) SHOWED THE PROSTATE WAS OCCUPIED BY LESION WITH STRONG, OBSCURING THE NORMAL PROSTATIC URETHRA. THE SAGITTAL IMAGES SHOWED THAT THE TUMOR EXTENDED DIRECTLY TO THE DORSAL CORTEX OF THE PUBIS, IT WAS SUGGESTED A MALIGNANT TUMOR WITH INTERNAL NECROSIS. A CONTRAST ENHANCED WHOLE BODY COMPUTED TOMOGRAPHY (CT) SHOWED NO OTHER CANCER. CHEMOTHERAPY WAS SELECTED AS TREATMENT. THE PATIENT RECEIVED 2 CHEMOTHERAPY COURSES; THIS WAS COMBINED WITH EXTERNAL BEAM RADIATION TREATMENT (EBRT) FOR THE PELVIS AT 45 GY/ 25 FRACTIONS IN ORDER TO TREAT THE OBTURATOR LYMPH NODE METASTASIS. FOURTEEN APPLICATIONS WERE INSERTED, ONE OF THE SPACEOAR HYDROGEL, THAT WAS USED TO AVOID ADVERSE EVENTS FOR THE RECTUM. AFTER THE HIGH-DOSE-RATE INTERSTITIAL BRACHYTHERAPY (HDR-ISBT), SERUM SQUAMOUS CELL CARCINOMA (SCC) MARKETS DECREASED FROM 3.3 TO 0.8 NG/ML, THE (MR) EVALUATED AT 1, 3, 4, 6, 10 MONTHS AFTER THE TREATMENT, THE CANCER REDUCED SIGNIFICANTLY. ACUTE AND LATE SIDE EFFECTS REPORTED, SIX MONTHS AFTER THE PATIENT COMPLAINED OF PERINEAL PAIN, TURBIDITY IN THE URINE AND THE MR DETECTED A PROSTATIC RECTAL FISTULA, A COLOSTOMY WAS PERFORMED TO RELIEVED PAIN AND INFLAMMATION. NO BIOCHEMICAL FAILURE RECURRENCE WAS OBSERVED 12 MONTHS AFTER THE SALVAGE TREATMENT. IT WAS UNKNOWN AT THE TIME OF THIS REPORT IS THE RELATIONSHIP BETWEEN THE FISTULA, PAIN AND INFLAMMATION WAS RELATED TO SPACEOAR DEVICE OR PLACEMENT PROCEDURE. THE PATIENT CURRENT CONDITION WAS UNKNOWN. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1881454 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention