MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPACEOAR VUE SYSTEM; ABSORBABLE PERIRECTAL SPACER

Model Number SV-2101

Device Problem Positioning Problem (3009)

Patient Problems Fistula (1862); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Ischemia (1942); Necrosis (1971); Pain (1994); Ulcer (2274); Discomfort (2330); Fluid Discharge (2686); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 09/30/2021

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 complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a problem 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 that spaceoar vue was implanted during a spaceoar vue placement procedure performed on (b)(6) 2021.Fiducials were administered transperineally and the procedure was done under general anesthesia.Low dose rate brachytherapy boost seeds were placed in the same procedure prior to the spaceoar vue placement.The patient experienced pain and discomfort a week after the placement procedure.During a 30 post placement computed tomography (ct) scan, on (b)(6) 2021, the patient was experiencing pain, bleeding, ulcer and evidence of the gel misplaced in the rectal wall.An endoscopy was performed, and it was noted that the last image slice showed some of the spaceoar vue hydrogel was injected in the rectal wall.The patient was treated with hyperbaric oxygen and will receive sucralfate enemas.The patient received 28 fractions of radiation treatment and received a diverting colostomy, which has reduced discomfort significantly.The patient reportedly, feels better.

Event Description

It was reported to boston scientific corporation that spaceoar vue was implanted during a spaceoar vue placement procedure performed on (b)(6), 2021.Fiducials were administered transperineally and the procedure was done under general anesthesia.Low dose rate brachytherapy boost seeds were placed in the same procedure prior to the spaceoar vue placement.The patient experienced pain and discomfort a week after the placement procedure.During a 30 post placement computed tomography (ct) scan, on (b)(6), 2021, the patient was experiencing pain, bleeding, ulcer and evidence of the gel misplaced in the rectal wall.An additional patient symptom of hematoma was noted.An endoscopy was performed, and it was noted that the last image slice showed some of the spaceoar vue hydrogel was injected in the rectal wall.The patient was treated with hyperbaric oxygen and will receive sucralfate enemas.The patient received 28 fractions of radiation treatment and received a diverting colostomy, which has reduced discomfort significantly.The patient reportedly, feels better.Additional information received on march 15, 2023.It was reported the patient had presented to their clinic on (b)(6), 2021, with rectal pain and constipation.He then returned on (b)(6), 2021, with complaints of rectal pain and rectal bleeding.A ct scan performed on (b)(6), 2021, confirmed the rectal wall ulcer.He was hospitalized from (b)(6), 2021, to (b)(6), 2021, due to a large rectal ulcer, rectal bleeding and rectal pain.Then, on (b)(6), 2022, the patient returned to the clinic with rectal pain and rectal bleeding.The patient was seen by their physician on (b)(6), 2022, at which time it was noted the patient had been experiencing rectal and perineal pain and seemed to have some drainage of the hydrogel directly after the procedure.It was reported the postoperative ct scan showed the hydrogel in place but with less separation than normal, so the physician believed some drained out.On (b)(6), 2022, the patient had a follow up appointment at which time their physician noted it appeared the rectal ulcer was enlarging compared to the flex sigmoidoscopy four months prior.The physician believed it was mucosa dying secondary to ischemia from the hydrogel being in the wall of the rectum.Then, on (b)(6), 2022, the patient presented to the hospital and a ct scan showed a recto-prostatic fistula.He was hospitalized from (b)(6), 2022, to (b)(6),2022 as a result.The patient underwent a laparoscopic sigmoid loop colostomy on (b)(6), 2022.On (b)(6), 2022, the patient returned to their clinic with complaints of urinating from his rectum.He was then diagnosed with a rectourethral fistula.Due to continued infections from the rectourethral fistula, the patient was given a suprapubic catheter on (b)(6), 2022.The patient also experienced emotional pain and suffering.The patient's outcome is unknown.

Manufacturer Narrative

Additional information: blocks a1, a2, b2, b3, b5, b6, b7, g2 and h6 have been updated based on additional information received march 15, 2023.Corrected fields: blocks b2 and b5 have been corrected.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: device problem code a1502 captures the reportable event of gel misplaced, non-vascular.Patient code e2330 captures the reportable event of pain.Patient code e0506 captures the reportable event of bleeding.Patient code e9284 captures the reportable event of an ulcer.Patient code e2327 captures the reportable event of necrosis.Patient code e1906 captures the reportable event of infection.

• Brand Name: SPACEOAR VUE SYSTEM
• Type of Device: ABSORBABLE PERIRECTAL SPACER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14172647
• MDR Text Key: 290459819
• Report Number: 3005099803-2022-02133
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

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: SV-2101
• Device Catalogue Number: SV-2101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/21/2022
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 04/06/2023
• 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): Hospitalization; Required Intervention; Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: Black Or African American