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 Codes	Dyspnea (1816); Pneumothorax (2012); Discomfort (2330)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus was notified of an adverse event for a patient participating in the strive post market registry study.Strive is a single-arm, prospective, multi-center, registry study to evaluate the long-term safety and effectiveness of the spiration valve system (svs) for the treatment of severe emphysema in a post-market setting.On (b)(6) 2025, the patient underwent a bronchoscopic lung volume reduction with three svs valves in the right upper lobe (rul).The patient experienced a large right pneumothorax post procedure on that same day, and a chest tube was placed.Additionally, this necessitated removal of this valve on (b)(6) 2025.The patient has two remaining valves in the rul.Pneumothorax improved and the chest tube was removed on (b)(6) 2025.On (b)(6) 2026, the patient was discharged on 4 liters (l) of oxygen with improved shortness of breath and activity.The patient has since had several follow-up visits and reports an improvement in her condition.It was reported that at the one month follow up appointment, the patient had some discomfort around the site of the insertion of the chest tube; however, on assessment, the incision was well-healed without any redness or swelling in the area.The patient reported that she has an easier time being able to get out of her chair into the bathroom or for short walks within the house.However, when the patient takes longer walks, she does still become dyspneic.She is using between 2 to 5 l of oxygen on her concentrator.She noted she has less dyspnea for non-exertional activities at home post-valves.The customer indicated that there was no device failure since pneumothorax is the main known risk of this procedure.The adverse event was assessed as device related and not procedure related.Upon further follow-up, the customer reported that pneumothorax began to improve after this valve was explanted on (b)(6) 2025.The pneumothorax was not believed to be related to the 2 remaining valves.There were no reports of further patient harm.
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 received from customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: h2, h4, h6, h11.The device was not returned to olympus for inspection and the reported failure was not confirmed.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.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: 24691800
• Report Number: 3004450998-2026-00026
• Device Sequence Number: 9653113
• Product Code: NJK
• UDI-Device Identifier: 00896506002309
• UDI-Public: 896506002309
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: PMA P180007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: WS507519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SVS-V7-00.; SVS-V9-00.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown