BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 9933088 · Received April 7, 2020

    Report

    Report Number
    3005099803-2020-01543
    Event Type
    Injury
    Date Received
    April 7, 2020
    Date of Event
    February 4, 2020
    Report Date
    June 11, 2020
    Manufacturer
    AUGMENIX, INC.
    Product Code
    OVB
    UDI-DI
    00864661000102
    PMA / PMN Number
    K181465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: PATIENT CODE 1994 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF PAIN REQUIRING TREATMENT.. DEVICE CODE 3009 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF GEL MISPLACED NON-VASCULAR. BLOCK H10: 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 · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPACEOAR WAS IMPLANTED DURING A SPACEOAR PROCEDURE ON (B)(6), 2019. ACCORDING TO THE COMPLAINANT, ON (B)(6), 2019 THE PATIENT COMPLAINED OF HEMORRHOIDS. THIS WAS TREATED WITH MIRALAX AND ANUSOL. BRIGHT RED BLOOD IN THE RECTUM WAS NOTICED DURING A TREATMENT VISIT ON (B)(6) 2019. THE RADIATION TREATMENT PLAN WAS COMPLETED ON (B)(6), 2019, WITH 7000 CENTIGRAY ADMINISTERED OVER 28 FRACTIONS BETWEEN (B)(6). DURING A ONE MONTH FOLLOW UP VISIT, ADDITIONAL PATIENT RECTAL COMPLAINTS AND HEMORRHOIDS WERE REPORTEDLY ADDRESSED WITH ANUSOL HYDROCORTISONE CREAM ON (B)(6) , 2019. ON B)(6) 2019, DURING AN UNSCHEDULED FOLLOW UP, THE PATIENT REPORTED PAIN AND PRESSURE WHEN SITTING WHICH WAS TREATED WITH PRESCRIPTION LIDOCAINE SUPPOSITORIES. A COLONOSCOPY WAS PERFORMED ON B)(6) , 2020 SHOWING A DISTAL RECTAL ULCER. A FOLLOWING MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE WAS DONE ON B)(6) , 2020 SHOWING A SMALL GAS FILLED DIVERTICULUM ARISING FROM THE ANTERIOR WALL OF THE DISTAL RECTUM JUST ABOVE THE ANUS, WITH MILD SOFT TISSUE ENHANCEMENT, NOT COMMUNICATING WITH THE PROSTATE OR URETHRA. REPORTEDLY, THE MRI SHOWS THE CAVITY IS INFERIOR TO THE PROSTATE AND NOT IN A HIGH DOSE AREA. THIS IS REPORTED TO FIT WITH THE INFERIOR PLACEMENT AND RECTAL WALL PERFORATION FROM SPACEOAR. THE REPORTED EVENT OF PAIN AND PRESSURE WHEN SITTING HAS GOTTEN BETTER BUT NOT COMPLETELY RESOLVED. REPORTEDLY, VIA A PHONE CLINICAL EVALUATION, THE PATIENT HAS CLINICALLY IMPROVED, THE PAIN IS MUCH BETTER. THE PATIENT HAD A DULL ACHE THAT IS BEING MANAGED WITH IBUPROFEN. THE PATIENT HAS BEEN REFERRED FOR HYPERBARIC OXYGEN TO START AFTER SIX MONTHS OF RADIATION. ***ADDIITONAL INFORMATION RECEIVED ON B)(6) , 2020*** AFTER TWO AND A HALF MONTHS POST COLONOSCOPY, THE PATIENT UNDEWENT A REPEAT SIGMOIDOSCOPY WHICH REVEALED A NEARLY COMPLETED HEALING OF THE DISTAL RECTAL ULCER AND DOES NOT NECESSITATE A REPEAT SIGMOIDOSCOPY.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE 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 WAS IMPLANTED DURING A SPACEOAR PROCEDURE ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2019 THE PATIENT COMPLAINED OF HEMORRHOIDS. THIS WAS TREATED WITH MIRALAX AND ANUSOL. BRIGHT RED BLOOD IN THE RECTUM WAS NOTICED DURING A TREATMENT VISIT ON (B)(6) 2019. THE RADIATION TREATMENT PLAN WAS COMPLETED ON (B)(6) 2019, WITH 7000 CENTIGRAY ADMINISTERED OVER 28 FRACTIONS BETWEEN (B)(6). DURING A ONE MONTH FOLLOW UP VISIT, ADDITIONAL PATIENT RECTAL COMPLAINTS AND HEMORRHOIDS WERE REPORTEDLY ADDRESSED WITH ANUSOL HYDROCORTISONE CREAM ON (B)(6) 2019. ON (B)(6) 2019, DURING AN UNSCHEDULED FOLLOW UP, THE PATIENT REPORTED PAIN AND PRESSURE WHEN SITTING WHICH WAS TREATED WITH PRESCRIPTION LIDOCAINE SUPPOSITORIES. A COLONOSCOPY WAS PERFORMED ON (B)(6) 2020 SHOWING A DISTAL RECTAL ULCER. A FOLLOWING MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE WAS DONE ON (B)(6) 2020 SHOWING A SMALL GAS FILLED DIVERTICULUM ARISING FROM THE ANTERIOR WALL OF THE DISTAL RECTUM JUST ABOVE THE ANUS, WITH MILD SOFT TISSUE ENHANCEMENT, NOT COMMUNICATING WITH THE PROSTATE OR URETHRA. REPORTEDLY, THE MRI SHOWS THE CAVITY IS INFERIOR TO THE PROSTATE AND NOT IN A HIGH DOSE AREA. THIS IS REPORTED TO FIT WITH THE INFERIOR PLACEMENT AND RECTAL WALL PERFORATION FROM SPACEOAR. THE REPORTED EVENT OF PAIN AND PRESSURE WHEN SITTING HAS GOTTEN BETTER BUT NOT COMPLETELY RESOLVED. REPORTEDLY, VIA A PHONE CLINICAL EVALUATION, THE PATIENT HAS CLINICALLY IMPROVED, THE PAIN IS MUCH BETTER. THE PATIENT HAD A DULL ACHE THAT IS BEING MANAGED WITH IBUPROFEN. THE PATIENT HAS BEEN REFERRED FOR HYPERBARIC OXYGEN TO START AFTER SIX MONTHS OF RADIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395758 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB AUGMENIX, INC. SO-2101 00864661000102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention