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

Model Number SV-1010

Device Problem Positioning Problem (3009)

Patient Problems Fever (1858); Micturition Urgency (1871); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Chills (2191); Dysuria (2684); Low White Blood Cell Count (4433); Urinary Incontinence (4572); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/10/2024

Event Type  Injury  

Manufacturer Narrative

Block h6: device code a1502 is being used to capture the reportable event of gel misplaced non-vascular.Patient code e2330 is being used to capture the reportable event of pain.Patient code e1906 is being used to capture the reportable event of unspecified infection.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a placement procedure performed under local anesthesia on (b)(6) 2023.Additionally, fiducial markers were placed transperineally.It was reported that the patient experienced a gel misplacement.The hydrogel misplacement occurred laterally to the posterior prostate space, infiltrating the prostate capsule and dissipating towards the right and anterior regions.The hydrogel seemed to be involving the prostate parenchyma.On (b)(6) 2023, the patient experienced a serious urinary tract infection.Additionally, the patient experienced fever, urinary tract pain, urinary urgency and incontinence.The patient was hospitalized from (b)(6) 2024, to (b)(6) 2024, as a result of these events.The treatment included piperacillin/tazobactam and fosfomycin medication, complete laboratory test, computerized tomography (ct), intravenous (iv) antibiotics, and magnetic resonance (mri).The ct and mri performed during hospitalization shown a significant and unexpected lateral and capsules placement of the spaceoar vue.It was decided to not proceed with the stereotactic body radiotherapy (sbrt) delivery, and temporarily suspend the procedure waiting for the hydrogel to reabsorb.It was also reported that the patient's urinary tract infection has been resolved.The patient symptoms were deemed as related to the spaceoar vue injection and hydrodissection procedure.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a placement procedure performed under local anesthesia on (b)(6) 2023.Additionally, fiducial markers were placed transperineally.It was reported that the patient experienced a gel misplacement.The hydrogel misplacement occurred laterally to the posterior prostate space, infiltrating the prostate capsule and dissipating towards the right and anterior regions.The hydrogel seemed to be involving the prostate parenchyma.On (b)(6) 2023, the patient experienced a serious urinary tract infection.Additionally, the patient experienced fever, urinary tract pain, urinary urgency and incontinence.The patient was hospitalized from (b)(6)2024, to (b)(6) 2024, as a result of these events.The treatment included piperacilline/tazobactam and fosfomycin medication, complete laboratory test, computerized tomography (ct), intravenous (iv) antibiotics, and magnetic resonance (mri).The ct and mri performed during hospitalization shown a significant and unexpected lateral and capsules placement of the spaceoar vue.It was decided to not proceed with the stereotactic body radiotherapy (sbrt) delivery, and temporarily suspend the procedure waiting for the hydrogel to reabsorb.It was also reported that the patient's urinary tract infection has been resolved.The patient symptoms were deemed as related to the spaceoar vue injection and hydrodissection procedure.Additional information.It was reported that patient experienced intermittent fever the night of the spaceoar placement procedure, additionally the patient experienced urinary urgency with incontinence, chills, and dysuria.The patient was treated with amoxicillin/clavulanate for 5 days and two tablets of levofloxacin on (b)(6), 2024.Blood tests were conducted and revealed slight lymphopenia.The urinary tests showed no signs of infection, the blood cultures (performed during the fever peak) and urinary cultures were negative.The autoantibody tests results were negative.A lower mri excluded an abscess collection, the intraprostatic and pelvic areas, showed a distended bladder with a slightly thickened wall, some small bladder diverticula with decidedly high-density fluid content, possible expression of bladder inflammation.An empirical antibiotic therapy with piperacillin/tazobactam and fosfomycin was started for suspicion of the urinary tract infection (uti).The patient's fever decreased gradually with a simultaneous but transitory increase in the inflammation indices without procalcitonin (pct) elevation.At discharge, the patient was consistently afebrile and an increase in c-reactive protein (pcr) (40 mg/dl) persisted.It was also reported that "given the appearance of hyperpyrexia after the procedure, it is likely to be an infection or systemic inflammatory reaction".

Manufacturer Narrative

Block h6: device code a1502 is being used to capture the reportable event of gel misplaced non-vascular.Patient code e2330 is being used to capture the reportable event of pain.Patient code e1906 is being used to capture the reportable event of unspecified infection.Patient code e2326 is being used to capture the reportable event of inflammation.Blcokh11: block b5 and block h6 (patient codes) have been updated based on additional information received on (b)(6), 2024.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a placement procedure performed under local anesthesia on (b)(6) 2024.Additionally, fiducial markers were placed transperineally.It was reported that the patient experienced a gel misplacement.The hydrogel misplacement occurred laterally to the posterior prostate space, infiltrating the prostate capsule and dissipating towards the right and anterior regions.The hydrogel seemed to be involving the prostate parenchyma.On (b)(6) 2024, the patient experienced a serious urinary tract infection.Additionally, the patient experienced fever, urinary tract pain, urinary urgency and incontinence.The patient was hospitalized from (b)(6) 2024, as a result of these events.The treatment included piperacilline/tazobactam and fosfomycin medication, complete laboratory test, computerized tomography (ct), intravenous (iv) antibiotics, and magnetic resonance (mri).The ct and mri performed during hospitalization shown a significant and unexpected lateral and capsules placement of the spaceoar vue.It was decided to not proceed with the stereotactic body radiotherapy (sbrt) delivery, and temporarily suspend the procedure waiting for the hydrogel to reabsorb.It was also reported that the patient's urinary tract infection has been resolved.The patient symptoms were deemed as related to the spaceoar vue injection and hydrodissection procedure.Additional information.It was reported that patient experienced intermittent fever the night of the spaceoar placement procedure, additionally the patient experienced urinary urgency with incontinence, chills, and dysuria.The patient was treated with amoxicillin/clavulanate for 5 days and two tablets of levofloxacin on (b)(6) 2024.Blood tests were conducted and revealed slight lymphopenia.The urinary tests showed no signs of infection, the blood cultures (performed during the fever peak) and urinary cultures were negative.The autoantibody tests results were negative.A lower mri excluded an abscess collection, the intraprostatic and pelvic areas, showed a distended bladder with a slightly thickened wall, some small bladder diverticula with decidedly high-density fluid content, possible expression of bladder inflammation.An empirical antibiotic therapy with piperacillin/tazobactam and fosfomycin was started for suspicion of the urinary tract infection (uti).The patient's fever decreased gradually with a simultaneous but transitory increase in the inflammation indices without procalcitonin (pct) elevation.At discharge, the patient was consistently afebrile and an increase in c-reactive protein (pcr) (40 mg/dl) persisted.It was also reported that "given the appearance of hyperpyrexia after the procedure, it is likely to be an infection or systemic inflammatory reaction".

Manufacturer Narrative

Block h6: device code a1502 is being used to capture the reportable event of gel misplaced non-vascular.Patient code e2330 is being used to capture the reportable event of pain.Patient code e1906 is being used to capture the reportable event of unspecified infection.Patient code e2326 is being used to capture the reportable event of inflammation.Block h11: block b5 has been corrected and updated based on additional information received on april 15, 2024.Additionally, blocks b3 and d6a were corrected.

• 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: 18717445
• MDR Text Key: 335521830
• Report Number: 2124215-2024-07272
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K182971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2024

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 Model Number: SV-1010
• Device Catalogue Number: SV-1010
• Device Lot Number: 0031130174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 02/22/2024; 04/15/2024
• Supplement Dates FDA Received: 03/19/2024; 05/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• 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): Other; Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male