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

Model Number SO-2101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930); Necrosis (1971); Urinary Retention (2119); Obstruction/Occlusion (2422); Abdominal Distention (2601); No Code Available (3191)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number.Therefore, the expiration and device manufacture dates are unknown.(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

It was reported to boston scientific corporation on december 17, 2019 that spaceoar was implanted between the prostate and anterior rectal wall during a spaceoar placement procedure performed on (b)(6) 2019.Reportedly, the procedure was done under local anesthesia and there were no issues noted during spaceoar placement.However, it was reported that the procedure took a long time and they needed a few extra sticks in order to correctly place the gold markers.According to the complainant, after the procedure, the patient tried to urinate before leaving the hospital but was unable to do so.The patient also declined to take cipro, an antibiotic administered by the hospital.Reportedly, the night of (b)(6) 2019, the patient went to the emergency room (er) for retention per the recommendation of the physician's assistant.At the er, the patient's white blood cell (wbc) count was elevated.The wbc count dropped back to a normal level after a few days of treatment.The patient's platelet count was normal.On (b)(6) 2019, a computerized tomography (ct) scan was performed in the er.A linear tract of extraluminal air between the rectum and prostate gland and additional fluid density was observed, which was reported to be expected after hydrogel implantation.On (b)(6) 2019, another ct scan was performed.The ct scan revealed no evidence of active bleeding.The ct scan showed that the internal mesenteric artery (ima) was occluded.There was a small bowel obstruction with dilation of the proximal jejunum.Increased fat stranding near sigmoid colon, which may represent colitis, was also observed.On (b)(6) 2019, a magnetic resonance imaging (mri) scan was also performed.A small amount of ill-defined fluid between the anterior wall of rectum and posterior prostate was observed.No rim-enhancing drainable collections were observed in the pelvis.There were signs of devitalization along the right lateral wall of the rectum and posterior prostate as well as in the intervening soft tissues.Continued small bowel obstruction and mild distention of the sigmoid colon were observed.Per the mri report, the spaceoar was placed correctly.On (b)(6) 2019, it was reported that the patient had urinary issues.A colonoscopy was performed and did not show any bowel issues.As of (b)(6) 2019, the patient had a diverting ostomy and it is unknown if the patient is still hospitalized.The patient has not received his stereotactic body radiation treatment yet.

Event Description

It was reported to boston scientific corporation on (b)(6), 2019 that spaceoar was implanted between the prostate and anterior rectal wall during a spaceoar placement procedure performed on (b)(6) 2019.Reportedly, the procedure was done under local anesthesia and there were no issues noted during spaceoar placement.However, it was reported that the procedure took a long time and they needed a few extra sticks in order to correctly place the gold markers.According to the complainant, after the procedure, the patient tried to urinate before leaving the hospital but was unable to do so.The patient also declined to take cipro, an antibiotic administered by the hospital.Reportedly, the night of (b)(6), 2019, the patient went to the emergency room (er) for retention per the recommendation of the physician's assistant.At the er, the patient's white blood cell (wbc) count was elevated.The wbc count dropped back to a normal level after a few days of treatment.The patient's platelet count was normal.On (b)(6) 2019, a computerized tomography (ct) scan was performed in the er.A linear tract of extraluminal air between the rectum and prostate gland and additional fluid density was observed, which was reported to be expected after hydrogel implantation.On (b)(6), 2019, another ct scan was performed.The ct scan revealed no evidence of active bleeding.The ct scan showed that the internal mesenteric artery (ima) was occluded.There was a small bowel obstruction with dilation of the proximal jejunum.Increased fat stranding near sigmoid colon, which may represent colitis, was also observed.On(b)(6) 2019, a magnetic resonance imaging (mri) scan was also performed.A small amount of ill-defined fluid between the anterior wall of rectum and posterior prostate was observed.No rim-enhancing drainable collections were observed in the pelvis.There were signs of devitalization along the right lateral wall of the rectum and posterior prostate as well as in the intervening soft tissues.Continued small bowel obstruction and mild distention of the sigmoid colon were observed.Per the mri report, the spaceoar was placed correctly.On (b)(6), 2019, it was reported that the patient had urinary issues.A colonoscopy was performed and did not show any bowel issues.As of (b)(6), 2019, the patient had a diverting ostomy and it is unknown if the patient is still hospitalized.The patient has not received his stereotactic body radiation treatment yet.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the expiration and device manufacture dates are unknown.Block h6: patient code 2119 captures the reportable event of urinary retention.Patient code 3191 is being used in lieu of an appropriate term for surgery.Patient code 1690 captures the reportable event of abscess.Patient code 1930 captures the reportable event of infection requiring treatment.Patient code 2422 captures the reportable event of bowel obstruction requiring surgical treatment.Evaluation conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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.Block h11: h6 (patient code) has been updated.

• Brand Name: SPACEOAR SYSTEM
• Type of Device: ABSORBABLE PERIRECTAL SPACER
• Manufacturer (Section D): AUGMENIX, INC.; 201 burlington road; bedford MA 01730
• MDR Report Key: 9586105
• MDR Text Key: 178332302
• Report Number: 3005099803-2020-00021
• Device Sequence Number: 1
• Product Code: OVB
• UDI-Device Identifier: 00864661000102
• UDI-Public: 00864661000102
• Combination Product (y/n): N
• PMA/PMN Number: K181465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: SO-2101
• Device Catalogue Number: SO-2101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 02/04/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention