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

BOSTON SCIENTIFIC CORPORATION SPACEOAR VUE SYSTEM; ABSORBABLE PERIRECTAL SPACER

Model Number SV-1010

Device Problem Positioning Problem (3009)

Patient Problems Abscess (1690); Anemia (1706); Fistula (1862); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Renal Failure (2041); Urinary Frequency (2275); Discomfort (2330); Obstruction/Occlusion (2422); Sleep Dysfunction (2517); Fluid Discharge (2686)

Event Date 03/21/2023

Event Type Injury

Event Description

Manufacturer Narrative

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted on (b)(6) 2023, under local anesthesia.Additionally fiducial markers were placed.A successful spaceoar vue placement was confirmed trough computerized tomography (ct) imaging.On march 21, 2023, the patient experienced a non-serious perineal pain.The pain was associated to be related to the spaceoar procedure.The perineal pain was treated with acetaminophen, tramadol and pregabalin, which was not effective.At the moment of this report, the patient still takes pregabalin based on the recommendation of a pain physician.The patient reported that he had a positive urine culture, however, the exams were performed one day before the procedure, on (b)(6) 2023.The patient was treated with antibiotics on (b)(6) 2023, and the radiation treatment started at the end of the course of antibiotics.On (b)(6) 2023, the patient started radiotherapy delivered via linear accelerator (linac).A total number of five fractions were administered.On (b)(6) 2023, the patient experienced a non- serious pelvic pain after the third fraction of radiation treatment.The event was treated with tramadol, acetaminophen, and pregabalin medication.On (b)(6) 2023, the patient experienced a non-serious urinary tract obstruction, and he was treated with tamsulosin.This adverse event has been deemed as possible related to the spaceoar vue procedure.On (b)(6) 2023, the patient experienced a serious suspected rectal fistula.The rectal fistula is potentially related to the spaceoar vue procedure, and it is related to the radiation treatment.At the time of this report, actions have not been taken to address the rectal fistula.It was reported that the spaceoar vue has dissolved and there is a lateral collection of fluid secondary to the fistula.The lateral collection might potentially be an abscess.The patient has had paint since the end of the stereotactic body radiotherapy (sbrt).Therefore, a magnetic resonance imaging (mri) and a rectoscopy were performed.Due to the patient's persistent pain, these exams have been repeated.Following images were reviewed, and it was suspected that the spaceoar vue could be located within the prostate capsule.It is important to note, that at the time of implant, no misplacement was considered.At the time of this report, the patient status is unknown.Additional information.It was reported that the patient's positive urinary culture was treated with bactrim medication.The event was resolved with sequelae on april 21, 2023.The event was noted to not be related to the spaceoar vue placement.On (b)(6) 2023, the patient's laboratory test results revealed signs of inflammation, the c-reactive protein was 46 mg/l, with normocytic anemia, possibly inflammatory (10.4 g/dl), but without hyperleukocytosis.The patient also showed slight renal insufficiency with serum creatinine concentration at 119 micromoles per liter and a glomerular filtration rate (gfr) of 51 ml/min.On (b)(6) 2023, due to the patient's non-serious perineal pain the patient underwent an mri and on (b)(6) 2023, the patient underwent an abdominopelvic scan with injection and opacification, additionally a rectoscopy was conducted.The mri and the abdominopelvic scan with injection and opacification showed a periprostatic pelvic fluid and gas collection on the left with a fistulous course to the rectum anterior wall.On (b)(6) 2023, as previously reported, the patient experienced a rectal fistula, the event led to a serious deterioration in the health of the patient, that resulted in life- threatening illness or injury.Based on the physician's assessment, the severity criteria are determined by the presence of impaired quality of life due to daily pelvic pain, resulting in a reduction in daily activities and a likelihood of requiring surgical treatment.While the condition is not life-threatening, it is considered serious due to its significant impact on the patient's daily life and the potential need for surgical intervention.At the time of this report, no actions have been taken to address the fistula.However, a rectoscopy is scheduled to determine treatment plan.The fistula was confirmed (on ct scan) by the physician to be a grade iii rectal fistula.As of (b)(6) 2023, the patient was having pain when sitting, discomfort when passing stools, nocturia (6-7 times per night), and flatulence with discharge of mucous when urinating.He had also experienced rectal bleeding for 24 hours post opacified scan that resolved spontaneously.The pelvic pain was noted to be related to a "probably superinfected collection secondary to a rectal fistula", described as between the rectum and the left lateral part of the prostate.The plan was for the patient to undergo temporary colostomy with antibiotics (type and duration) to be determined based on a sample taken at the time of the temporary colostomy.It was reported that the patient's colostomy surgery was scheduled for (b)(6) 2023.

Manufacturer Narrative

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 e172001 is being used to capture the reportable event of abscess.Patient code e2328 is being used to capture the reportable event of obstruction.Patient code e2330 is being used to capture the reportable event of pain.Patient code e2326 is being used to capture the reportable event of inflammation.Block h11 blocks b5 and h6 (patient and impact codes) have been updated, based on additional information received on january 31, 2023.

Manufacturer Narrative

: 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 e172001 is being used to capture the reportable event of abscess.Patient code e2328 is being used to capture the reportable event of obstruction.Patient code e2330 is being used to capture the reportable event of pain.Patient code e2326 is being used to capture the reportable event of inflammation.Block b5 correction.Block h6 (patient codes) has been updated and corrected, based on additional information received on february 29, 2024.

Event Description

Procedure summary.It was reported to boston scientific corporation that a spaceoar vue device was implanted on (b)(6) 2023, under local anesthesia.Additionally fiducial markers were placed.Event summary.A successful spaceoar vue placement was confirmed trough computerized tomography (ct) imaging.On march 21, 2023, the patient experienced a non-serious perineal pain.The pain was associated to be related to the spaceoar procedure.The perineal pain was treated with acetaminophen, tramadol and pregabalin, which was not effective.At the moment of this report, the patient still takes pregabalin based on the recommendation of a pain physician.The patient reported that he had a positive urine culture, however, the exams were performed one day before the procedure, on march 20,2023.The patient was treated with antibiotics on march 22, 2023, and the radiation treatment started at the end of the course of antibiotics.On april 20, 2023, the patient started radiotherapy delivered via linear accelerator (linac).A total number of five fractions were administered.On april 22, 2023, the patient experienced a non- serious pelvic pain after the third fraction of radiation treatment.The event was treated with tramadol, acetaminophen, and pregabalin medication.On october 17, 2023, the patient experienced a non-serious urinary tract obstruction, and he was treated with tamsulosin.This adverse event has been deemed as possible related to the spaceoar vue procedure.On november 27, 2023, the patient experienced a serious suspected rectal fistula.The rectal fistula is potentially related to the spaceoar vue procedure, and it is related to the radiation treatment.At the time of this report, actions have not been taken to address the rectal fistula.It was reported that the spaceoar vue has dissolved and there is a lateral collection of fluid secondary to the fistula.The lateral collection might potentially be an abscess.The patient has had paint since the end of the stereotactic body radiotherapy (sbrt).Therefore, a magnetic resonance imaging (mri) and a rectoscopy were performed.Due to the patient's persistent pain, these exams have been repeated.Following images were reviewed, and it was suspected that the spaceoar vue could be located within the prostate capsule.It is important to note, that at the time of implant, no misplacement was considered.Patient status at the time of this report, the patient status is unknown.Additional information.It was reported that the patient positive urinary culture was treated with bactrim medication.The event was resolved with sequelae on april 21, 2023.The event was not related to the spaceoar vue placement.On november 14, 2023, the patient's laboratory test results revealed signs of inflammation, the c-reactive protein was 46 mg/l, with normocytic anemia, possibly inflammatory (10.4 g/dl), but without hyperleukocytosis.The patient also showed slight renal insufficiency with serum creatinine concentration at 119 micromoles per liter and a glomerular filtration rate (gfr) of 51 ml/min.On november 22, 2023, due to the patient non-serious perineal pain the patient underwent an mri and on november 27, 2023, the patient underwent an abdominopelvic scan with injection and opacification, additionally a rectoscopy was conducted.The mri and the abdominopelvic scan with injection and opacification showed a periprostatic pelvic fluid and gas collection on the left with a fistulous course to the rectum anterior wall.On november 27, 2023, as previously reported, the patient experienced a rectal fistula, the event led to a serious deterioration in the health of the patient, that resulted in life- threatening illness or injury.Based on the physician's assessment, the severity criteria are determined by the presence of impaired quality of life due to daily pelvic pain, resulting in a reduction in daily activities and a likelihood of requiring surgical treatment.While the condition is not life-threatening, it is considered serious due to its significant impact on the patient's daily life and the potential need for surgical intervention.At the time of this report, no actions have been taken to address the fistula.However, a rectoscopy is scheduled to determine treatment plan.The fistula was confirmed (on ct scan) by the physician to be a grade iii rectal fistula.As of december 1, 2023, the patient was having pain when sitting, discomfort when passing stools, nocturia (6-7 times per night), and flatulence with discharge of mucous when urinating.He had also experienced rectal bleeding for 24 hours post opacified scan that resolved spontaneously.The pelvic pain was noted to be related to a "probably superinfected collection secondary to a rectal fistula", described as between the rectum and the left lateral part of the prostate.The plan was for the patient to undergo temporary colostomy with antibiotics (type and duration) to be determined based on a sample taken at the time of the temporary colostomy.It was reported that the patient's colostomy surgery was scheduled for (b)(6) 2024.

Event Description

Procedure summary.It was reported to boston scientific corporation that a spaceoar vue device was implanted on (b)(6) 2023, under local anesthesia.Additionally fiducial markers were placed.Event summary.A successful spaceoar vue placement was confirmed trough computerized tomography (ct) imaging.On (b)(6) 2023, the patient experienced a non-serious perineal pain.The pain was associated to be related to the spaceoar procedure.The perineal pain was treated with acetaminophen, tramadol and pregabalin, which was not effective.At the moment of this report, the patient still takes pregabalin based on the recommendation of a pain physician.The patient reported that he had a positive urine culture, however, the exams were performed one day before the procedure, on (b)(6) 2023.The patient was treated with antibiotics on (b)(6) 2023, and the radiation treatment started at the end of the course of antibiotics.On (b)(6) 2023, the patient started radiotherapy delivered via linear accelerator (linac).A total number of five fractions were administered.On (b)(6) 2023, the patient experienced a non- serious pelvic pain after the third fraction of radiation treatment.The event was treated with tramadol, acetaminophen, and pregabalin medication.On (b)(6) 2023, the patient experienced a non-serious urinary tract obstruction, and he was treated with tamsulosin.This adverse event has been deemed as possible related to the spaceoar vue procedure.On (b)(6) 2023, the patient experienced a serious suspected rectal fistula.The rectal fistula is potentially related to the spaceoar vue procedure, and it is related to the radiation treatment.At the time of this report, actions have not been taken to address the rectal fistula.It was reported that the spaceoar vue has dissolved and there is a lateral collection of fluid secondary to the fistula.The lateral collection might potentially be an abscess.The patient has had paint since the end of the stereotactic body radiotherapy (sbrt).Therefore, a magnetic resonance imaging (mri) and a rectoscopy were performed.Due to the patient's persistent pain, these exams have been repeated.Following images were reviewed, and it was suspected that the spaceoar vue could be located within the prostate capsule.It is important to note, that at the time of implant, no misplacement was considered.Patient status at the time of this report, the patient status is unknown.Additional information.It was reported that the patient positive urinary culture was treated with bactrim medication.The event was resolved with sequelae on april 21, 2023.The event was not related to the spaceoar vue placement.On (b)(6) 2023, the patient's laboratory test results revealed signs of inflammation, the c-reactive protein was 46 mg/l, with normocytic anemia, possibly inflammatory (10.4 g/dl), but without hyperleukocytosis.The patient also showed slight renal insufficiency with serum creatinine concentration at 119 micromoles per liter and a glomerular filtration rate (gfr) of 51 ml/min.On (b)(6) 2023, due to the patient non-serious perineal pain the patient underwent an mri and on november 27, 2023, the patient underwent an abdominopelvic scan with injection and opacification, additionally a rectoscopy was conducted.The mri and the abdominopelvic scan with injection and opacification showed a periprostatic pelvic fluid and gas collection on the left with a fistulous course to the rectum anterior wall.On(b)(6) 2023, as previously reported, the patient experienced a rectal fistula, the event led to a serious deterioration in the health of the patient, that resulted in life- threatening illness or injury.Based on the physician's assessment, the severity criteria are determined by the presence of impaired quality of life due to daily pelvic pain, resulting in a reduction in daily activities and a likelihood of requiring surgical treatment.While the condition is not life-threatening, it is considered serious due to its significant impact on the patient's daily life and the potential need for surgical intervention.At the time of this report, no actions have been taken to address the fistula.However, a rectoscopy is scheduled to determine treatment plan.The fistula was confirmed (on ct scan) by the physician to be a grade iii rectal fistula.As of (b)(6) 2023, the patient was having pain when sitting, discomfort when passing stools, nocturia (6-7 times per night), and flatulence with discharge of mucous when urinating.He had also experienced rectal bleeding for 24 hours post opacified scan that resolved spontaneously.The pelvic pain was noted to be related to a "probably superinfected collection secondary to a rectal fistula", described as between the rectum and the left lateral part of the prostate.The plan was for the patient to undergo temporary colostomy with antibiotics (type and duration) to be determined based on a sample taken at the time of the temporary colostomy.It was reported that the patient's colostomy surgery was scheduled for (b)(6) 2024.Additional information.On (b)(6) 2024 the patient underwent a lateral colostomy for a temporary stool diversion, secondary to the rectal fistula.It was also indicated that the patient experienced a grade 2 radiation proctitis.Additionally, the patient was noted to be in treatment for a left periprostatic abscess.The patient was discharged on (b)(6) 2024.

Manufacturer Narrative

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 e172001 is being used to capture the reportable event of abscess.Patient code e2328 is being used to capture the reportable event of obstruction.Patient code e2330 is being used to capture the reportable event of pain.Patient code e2326 is being used to capture the reportable event of inflammation.Block h11 the following field have been updated based on additional information received on april 03, 2024: block b5 and block h6 (impact codes).

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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

farshad fahimi

4100 hamline avenue north

building c

saint paul, MN 55112

MDR Report Key

18378639

MDR Text Key

331175312

Report Number

2124215-2023-71405

Device Sequence Number

Product Code

OVB

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K182971

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Other,Foreign,Company Representative

Reporter Occupation

Physician

Type of Report

Initial,Followup,Followup,Followup

Report Date

04/22/2024

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 Expiration Date

03/27/2024

Device Model Number

SV-1010

Device Catalogue Number

SV-1010

Device Lot Number

0029642346

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Yes

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

12/21/2023

Supplement Dates Manufacturer Received

01/31/2024
02/29/2024
04/03/2024

Supplement Dates FDA Received

02/26/2024
03/25/2024
04/22/2024

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Date Device Manufactured

03/28/2022

Is the Device Single Use?

Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Other;

Patient Age

76 YR

Patient Sex

Male

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

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