BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACEOAR VUE? SYSTEM - 10ML

    MDR report key: 23140001 · Received September 24, 2025

    Report

    Report Number
    2124215-2025-67400
    Event Type
    Death
    Date Received
    September 24, 2025
    Date of Event
    August 1, 2025
    Report Date
    October 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    UDI-DI
    00864661000140
    PMA / PMN Number
    K182971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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, 08/01/2025, WAS CHOSEN AS THE BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT 08/27/2025. BLOCKS D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: DEVICE CODE A1502 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF GEL MISPLACED NON-VASCULAR. PATIENT CODE E2314 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF FISTULA. PATIENT CODE E0306 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF SEPSIS. IMPACT CODE F02 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF DEATH. BLOCK H11: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCKH11: BLOCK H6 (PATIENT CODES) WAS CORRECTED.

    Additional Manufacturer Narrative · 0

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, 08/01/2025, WAS CHOSEN AS THE BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT 08/27/2025. THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. DEVICE CODE A1502 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF GEL MISPLACED NON-VASCULAR. PATIENT CODE E2314 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF FISTULA. PATIENT CODE E0306 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF SEPSIS. IMPACT CODE F02 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF DEATH. BLOCK H11: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A SPACEOAR VUE PROCEDURE AND FIDUCIAL MARKERS PLACEMENT SUBSEQUENTLY DEVELOPED A FISTULA. APPROXIMATELY TWO WEEKS AFTER THE PLACEMENT PROCEDURE, A LOW DOSE RATE (LDR) SEED PLACEMENT WAS PERFORMED. DURING POST-BRACHYTHERAPY COMPUTED TOMOGRAPHY (CT) IMAGING, SIGNS OF A FISTULA WERE OBSERVED. SHORTLY THEREAFTER, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND LATER PASSED AWAY DUE TO SEPSIS. THE SPACEOAR WAS IMPLANTED ON (B)(6) 2024, THERE WERE NO ISSUES WITH THE SPACEOAR IMPLANT, HYDRODISSECTION WENT FINE, THE NEEDLE APPEARED TO BE IN THE CORRECT SPOT. THE APPLIER PHYSICIAN THOUGHT THERE MAY HAVE BEEN SOME NEEDLE MOVEMENT WHILE INJECTING BUT WAS NOT ABLE TO CONFIRM. PATIENT HAD CT 2 MONTHS LATER FOR DOSIMETRY/TREATMENT PLANNING FOR PLANNED FOLLOW UP STEREOTACTIC BODY RADIATION THERAPY (SBRT). AT THAT TIME, THE HYDROGEL WAS IN THE CORRECT POSITION SUPERIORLY. INFERIORLY, THERE MAY HAVE BEEN SOME GEL PUSHING INTO THE RECTUM VERSUS INFILTRATING THE RECTUM. THE PHYSICIAN SHOWED SOME IMAGES AND NOTED THAT THE INFERIOR AREA WAS SUSPICIOUS OF RECTAL WALL INFILTRATION. THE SBRT WAS DELIVERED VIA 5 TREATMENTS BETWEEN (B)(6) 2024 AND (B)(6) 2024. PATIENT WAS SEEN FOR FOLLOW-UP ON (B)(6) 2025 AND HAD SOME MUCUS IN THE STOOL. HE WAS PRESCRIBED RECTAL SUPPOSITORIES FOR SUSPECTED PROCTITIS. THE PHYSICIAN HAD NO FURTHER FOLLOW UPS WITH THE PATIENT BUT KEPT IN CONTACT WITH THE PATIENT'S OTHER TREATING PHYSICIANS. IN (B)(6) 2025, THE PATIENT PRESENTED TO THE UROLOGIST FOR URINE COMING FROM THE RECTUM. THE PATIENT WAS DIAGNOSED WITH A URETHRAL-RECTAL FISTULA. THE FISTULA WAS DESCRIBED AS SMALL AND CLEAN AS THE RECTUM DID NOT HAVE STOOL COMING THROUGH IT, A CONSEQUENCE OF THE PATIENT'S PREEXISTING PERMANENT COLOSTOMY. A CATHETER WAS PLACED TO DIVERT THE URINE, SO IT WAS NOT GOING THROUGH THE FISTULA, AND THE PATIENT WAS REFERRED TO A GI SURGEON AT A DIFFERENT FACILITY AND PLANNED TO HAVE UNSPECIFIED SURGICAL RECONSTRUCTION. THE DAY PRIOR TO THE SCHEDULED SURGERY, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH UNKNOWN SYMPTOMS. HE DIED OF UROSEPSIS ON AN UNSPECIFIED DATE. IT IS UNKNOWN IF AUTOPSY WAS PERFORMED. THE PHYSICIAN STATED THAT HE DID NOT FEEL LIKE THE FISTULA AND SUBSEQUENT EVENTS WERE DUE TO A PRODUCT PROBLEM. HE STATED THAT THE EVENTS AND OUTCOME WERE DUE TO SEVERAL FACTORS INCLUDING SOME RECTAL WALL INFILTRATION, POOR BLOOD SUPPLY TO THE RECTUM DUE TO THE PREVIOUS SURGERY RESULTING IN A RECTAL STUMP, AND RADIATION THERAPY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A SPACEOAR VUE PROCEDURE AND FIDUCIAL MARKERS PLACEMENT SUBSEQUENTLY DEVELOPED A FISTULA. APPROXIMATELY TWO WEEKS AFTER THE PLACEMENT PROCEDURE, A LOW DOSE RATE (LDR) SEED PLACEMENT WAS PERFORMED. DURING POST-BRACHYTHERAPY COMPUTED TOMOGRAPHY (CT) IMAGING, SIGNS OF A FISTULA WERE OBSERVED. SHORTLY THEREAFTER, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND LATER PASSED AWAY DUE TO SEPSIS. THE SPACEOAR WAS IMPLANTED ON (B)(6) 2024, THERE WERE NO ISSUES WITH THE SPACEOAR IMPLANT, HYDRODISSECTION WENT FINE, THE NEEDLE APPEARED TO BE IN THE CORRECT SPOT. THE APPLIER PHYSICIAN THOUGHT THERE MAY HAVE BEEN SOME NEEDLE MOVEMENT WHILE INJECTING BUT WAS NOT ABLE TO CONFIRM. PATIENT HAD CT 2 MONTHS LATER FOR DOSIMETRY/TREATMENT PLANNING FOR PLANNED FOLLOW UP STEREOTACTIC BODY RADIATION THERAPY (SBRT). AT THAT TIME, THE HYDROGEL WAS IN THE CORRECT POSITION SUPERIORLY. INFERIORLY, THERE MAY HAVE BEEN SOME GEL PUSHING INTO THE RECTUM VERSUS INFILTRATING THE RECTUM. THE PHYSICIAN SHOWED SOME IMAGES AND NOTED THAT THE INFERIOR AREA WAS SUSPICIOUS OF RECTAL WALL INFILTRATION. THE SBRT WAS DELIVERED VIA 5 TREATMENTS BETWEEN (B)(6) 2024. PATIENT WAS SEEN FOR FOLLOW-UP ON (B)(6) 2025 AND HAD SOME MUCUS IN THE STOOL. HE WAS PRESCRIBED RECTAL SUPPOSITORIES FOR SUSPECTED PROCTITIS. THE PHYSICIAN HAD NO FURTHER FOLLOW UPS WITH THE PATIENT BUT KEPT IN CONTACT WITH THE PATIENT'S OTHER TREATING PHYSICIANS. IN (B)(6) 2025, THE PATIENT PRESENTED TO THE UROLOGIST FOR URINE COMING FROM THE RECTUM. THE PATIENT WAS DIAGNOSED WITH A URETHRAL-RECTAL FISTULA. THE FISTULA WAS DESCRIBED AS SMALL AND CLEAN AS THE RECTUM DID NOT HAVE STOOL COMING THROUGH IT, A CONSEQUENCE OF THE PATIENT'S PREEXISTING PERMANENT COLOSTOMY. A CATHETER WAS PLACED TO DIVERT THE URINE, SO IT WAS NOT GOING THROUGH THE FISTULA, AND THE PATIENT WAS REFERRED TO A GI SURGEON AT A DIFFERENT FACILITY AND PLANNED TO HAVE UNSPECIFIED SURGICAL RECONSTRUCTION. THE DAY PRIOR TO THE SCHEDULED SURGERY, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH UNKNOWN SYMPTOMS. HE DIED OF UROSEPSIS ON AN UNSPECIFIED DATE. IT IS UNKNOWN IF AUTOPSY WAS PERFORMED. THE PHYSICIAN STATED THAT HE DID NOT FEEL LIKE THE FISTULA AND SUBSEQUENT EVENTS WERE DUE TO A PRODUCT PROBLEM. HE STATED THAT THE EVENTS AND OUTCOME WERE DUE TO SEVERAL FACTORS INCLUDING SOME RECTAL WALL INFILTRATION, POOR BLOOD SUPPLY TO THE RECTUM DUE TO THE PREVIOUS SURGERY RESULTING IN A RECTAL STUMP, AND RADIATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2493349 SPACEOAR VUE? SYSTEM - 10ML ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SV-2101 00864661000140

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Other| H| D