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 Problem Insufficient Information (4580)

Event Date 03/14/2024

Event Type  Death  

Manufacturer Narrative

Block b2: date of death: this date has been estimated to (b)(6) 2024, based on the date the patient received the spaceoar and was re admitted to the hospital.Block b7: other relevant history: two patients were noted to have received spaceoar on the same day.It is unclear at the time of this report whether this patient history belongs to this deceased patient or the second patient with no device or patient complications.Block d4 and h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf impact code f02 captures the reportable event of death.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar vue placement procedure on (b)(6) 2024.The procedure was performed with local anesthesia.It was a successful procedure.After the procedure, on (b)(6) 2024 the patient was admitted to hospital due to unspecified health concerns.The reason for hospitalization was noted to be unrelated to the use of spaceoar vue.The patient died on unknown date.According to the placing team, the event and subsequent patient death was deemed unlikely to be related to the placing procedure and the spaceoar vue device.No autopsy 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19169304
• MDR Text Key: 340896290
• Report Number: 2124215-2024-24058
• Device Sequence Number: 1
• Product Code: OVB
• UDI-Device Identifier: 00864661000140
• UDI-Public: 00864661000140
• 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
• Type of Report: Initial
• Report Date: 04/23/2024

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?: 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: 03/29/2024
• Initial Date FDA Received: 04/23/2024
• 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): Death
• Patient Sex: Male