MAUDE Adverse Event Report: GYRUS ACMI, INC. VALVE IN CARTRIDGE, 9MM; SPIRATION VALVE

Model Number	SVS-V9-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Chronic Obstructive Pulmonary Disease (COPD) (2237)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent spiration valve placement procedure and 6 spiration valves were placed in the left upper lung.The patient had acute exacerbation of chronic obstructive pulmonary disease (copd) approximately 8 days after valve placement.The patient was then admitted to the hospital and was given intravenous (iv) medication.The patient was discharged without further injury.There were no further reports of patient harm.The physician indicated that the event was related to the devices and procedure.This report is 6 of 6 valves.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
No additional information was received from the customer.
Additional Manufacturer Narrative
Correction to a previously reported aware date in the prior mdr.G3 aware date corrected from (b)(6) 2026 to (b)(6) 2025.
Event or Problem Description
No additional information was received from the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: h6.The device was not returned for evaluation; therefore, a definitive root cause could not be determined.The most probable cause was not established; the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: VALVE IN CARTRIDGE, 9MM
• Common Device Name: SPIRATION VALVE
• Manufacturer (Section D): GYRUS ACMI, INC.; 6675 185th ave ne; redmond WA 98052
• Manufacturer (Section G): GYRUS ACMI, INC.; 6675 185th ave ne; redmond WA 98052
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 24448638
• Report Number: 3004450998-2026-00009
• Device Sequence Number: 10301142
• Product Code: NJK
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: PMA P180007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2026

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
• Operator of Device: Health Professional
• Device Model Number: SVS-V9-00
• Device Lot Number: WS502698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/23/2026; 05/28/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/30/2026; 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Race: White