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	Pneumothorax (2012); Loss of consciousness (2418)
Date of Event	01/21/2026
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.The subject (b)(6)., enrolled in the strive study, underwent therapeutic multiple spiration valve placements under general anesthesia on (b)(6) 2026.On (b)(6) 2026, the patient was taken to an emergency room, after a neighbor found her on the floor and unable to get up.At the hospital, doctors discovered that she had a large right pneumothorax.They placed a chest tube to help re expand the lung.On (b)(6) 2026, she was transferred to another (b)(6) hospital.On (b)(6) 2026 doctors tried a clamp trial temporarily clamping the chest tube to see if her lung would stay expanded, but a small collapse was still seen on the chest x ray.They repeated the clamp trial from (b)(6), and this time the x ray showed no lung collapse, so the chest tube was removed on (b)(6) 2026.However, on (b)(6) 2026, a new chest x ray showed that her lung had collapsed again.Another chest tube was placed.On (b)(6) 2026 the chest tube was fitted with a heimlich valve and she was discharged from the hospital on (b)(6) 2026 and chest tube was removed 13 days post-discharge on (b)(6) 2026.Patient remained in the hospital for 15 days.Pneumothorax is reported as resolved.This is report 2 of 4.
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 the customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Updated fields- h2, h3, h4, h6 and h11.A review of the device history record found no deviations that could have caused or contributed to the reported issue.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 and the complaint was not confirmed.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
This supplemental report is a correction made to the previously submitted g3 date- date received by the manufacturer.The correct date is 3/19/2026.

• 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: 24475785
• Report Number: 3004450998-2026-00015
• Device Sequence Number: 10332276
• Product Code: NJK
• UDI-Device Identifier: 00896506002309
• UDI-Public: 896506002309
• Combination Product (Y/N): N
• Initial Reporter State: IL
• PMA/510(K) Number: PMA P180007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2026

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: WS502410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/19/2026; 04/22/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/24/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 50 KG