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

Model Number SV-2101

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

Patient Problems Cardiac Arrest (1762); Nausea (1970); Vomiting (2144); Syncope/Fainting (4411)

Event Date 08/30/2021

Event Type  Death  

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 approximately 0.5 to 1 cc of spaceoar vue hydrogel from a spaceoar vue device was implanted during a spaceoar vue and fiducial marker placement procedure, performed on (b)(6) 2021.Three fiducial markers were placed into the prostate with a transperineal approach under ultrasound guidance.Prior to the procedure, the patient was administered 23cc of 1% lidocaine to the perineum and 2% topical lidocaine jelly.It was reported that the patient had a large gland and was "sensitive to pain".The patient also received a fleet enema, 500 mg of oral ciprofloxacin, 80 mg of intramuscular tobramycin, and a chlorhexidine prep stick was used.It was reported that during the procedure, the patient was awake and conversational and was aware of his surroundings.The spaceoar vue kit was properly assembled.While performing hydrodissection, there was clear visibility of the perirectal fat layer.Under ultrasound guidance, the needle was placed in the perirectal fat space and 2 to 3 cc of sterile injectable saline was used to open the space.Via sagittal and axial ultrasound views, the needle was confirmed to be properly positioned and the space was opening properly.Aspiration was performed successfully to ensure there was no blood in the syringe, and that the needle was not placed intravascularly.The saline syringe was replaced with the spaceoar vue bioset and the placing team confirmed the needle was not moved and was still in the correct location.When injecting spaceoar vue hydrogel, clear separation of the space was not seen, also reported as, "the gel did not provide lift initially to the prostate in the sagittal view".To be cautious, the applier aborted the procedure to ensure the gel did not end up asymmetric and affect radiation planning.It was reported that 0.5 to 1 cc of hydrogel had been injected prior to discontinuing the procedure.After the procedure was discontinued, the rectal ultrasound probe was removed from the patient's rectum.A few seconds after the rectal ultrasound probe was removed, the patient said that he was nauseous and began to vomit.The patient experienced a syncopal event.Additional nursing staff was called to assist the patient, because it was believed he was experiencing a vasovagal response.The patient became unresponsive, and a code blue was called.Additionally, emergency services were called.The patient was administered oxygen, fluids, and cpr for 45 minutes.The patient was then transferred to the emergency department (ed).The patient was admitted to the neurology intensive care unit (icu) in a comatose state.Chest and head computed tomography angiography (cta) were performed (results not reported to bsc).Additional information revealed that the patient died on an unspecified date.It was noted in the patient's file that the patient suffered a "heart attack secondary to the vasovagal event".According to the placing team, these events and subsequent patient death were deemed unrelated to the placing procedure and the spaceoar vue device.However, no autopsy was performed and no additional information regarding the patient has been received to date.The relation to the spaceoar vue device and placing procedure to cause of death was unconfirmed.

• 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: 13716430
• MDR Text Key: 286934838
• Report Number: 3005099803-2022-01318
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 03/09/2022

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: SV-2101
• Device Catalogue Number: SV-2101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 03/09/2022
• 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): Other; Death
• Patient Sex: Male
• Patient Race: Black Or African American