MAUDE Adverse Event Report: AUGMENIX, INC. SPACEOAR SYSTEM; ABSORBABLE PERIRECTAL SPACER

Model Number SO-2101

Device Problem Positioning Problem (3009)

Patient Problems Edema (1820); Inflammation (1932); Muscle Spasm(s) (1966); Pain (1994); Ulcer (2274); Injury (2348); Fluid Discharge (2686)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: date the article was published.Exact date of event is unknown.The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.Literature source: dinh, tru-khang, et al."a case of rectal ulcer during intensity modulated radiotherapy for prostate cancer using hydrogel spacer" urologypractice, vol.7, 158-161, march 1st 2020.Doi: 10.1097/upj.0000000000000071.(b)(4).The device was 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 medwatch will be filed.

Event Description

Boston scientific corporation became aware of an event through the article "a case of rectal ulcer during intensity modulated radiotherapy for prostate cancer using hydrogel spacer" written by tru-khang t.Dinh, et al.A board certified urologist placed gold prostate fiducials and hydrogel rectal spacer transperineally under ultrasound guidance 19 days before starting treatment.Reportedly the procedure was performed under local anesthesia.The patient tolerated the procedure well and there were no reported complications.Pretreatment pelvic magnetic resonance imaging (mri) confirmed placement of the spacer in the perirectal space.The patient underwent a course of intensity modulated radiation therapy (imrt) using volumetric arc therapy to the prostate and proximal seminal vesicles.Rectal enema was performed before computerized tomography (ct) simulation and daily image guidance with on-board cone beam ct was used.Early in the treatment course the patient had no gastrointestinal (gi) symptoms.As radiation dose increased, the patient began noticing rectal urgency, mucous discharge and aching perirectal pain.Reportedly, there was no hematochezia.Reportedly, the pain initially improved with nonsteroidal ant-inflammatory drugs and bismuth subsalicylate, but the patient continued to have frequent bowel movements with mucous.As the radiation dose continued to increase, the patient had increasing proctitis (inflammation) consisting of rectal urgency and frequency as well as continued mucous discharge.The patient was treated with hydro-cortisone rectal suppositories with modest improvement in symptoms.The patient was able to complete treatment with stable rectal symptoms.One week after completing treatment the patient presented to the emergency department with 3 days of crescendo rectal pain, rectal urgency every 20 minutes, and spasm.Ct of the abdomen and pelvis revealed perirectal fat stranding and edema, but no anatomical defect was identified.The patient was treated conservatively with stool softeners and pain medication.Flexible sigmoidoscopy obtained after discharge from the hospital revealed an 18 mm ulcer with associated proctitis at the anterior rectal wall.Subsequent mri of the pelvis demonstrated that the ulcer was contiguous with a pseudo-lumen in the region formerly occupied by spaceoar.The patient underwent 40 daily dives of hyperbaric oxygen and experienced improvement in symptoms halfway through the treatments.By the end of this course, 3 months after completing radiotherapy, rectal symptoms had nearly returned to baseline.Repeat flexible sigmoidoscopy showed improvement in the rectal ulcer and resolution of associated proctitis.Reportedly, the patient has completely recovered, is asymptomatic and without disease.

• Brand Name: SPACEOAR SYSTEM
• Type of Device: ABSORBABLE PERIRECTAL SPACER
• Manufacturer (Section D): AUGMENIX, INC.; 201 burlington road; bedford MA 01730
• Manufacturer (Section G): AUGMENIX, INC.; 201 burlington road; bedford MA 01730
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9881066
• MDR Text Key: 189611261
• Report Number: 3005099803-2020-01328
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SO-2101
• Device Catalogue Number: SO-2101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2020
• Initial Date FDA Received: 03/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR