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	Pneumonia (2011)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
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
Report 3 of 6.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) 2024 the patient underwent a therapeutic bronchoscopic lung volume reduction procedure during which multiple spiration valves were placed.Four 9mm valves and two 5mm valves were placed in an unspecified lobe/location.On (b)(6) 2026, the patient experienced cough, shortness of breath and fever.A sputum culture was performed which identified very light growth of stenotrophomonas maltophilia.The patient was hospitalized for pneumonia, received antibiotic treatment, and the endobronchial valves were removed.The patient improved and was discharged on an unspecified date.
Event or Problem Description
The physician reported that this is not a device related infection; the patient just got pneumonia one year after the valve insertion.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.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.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: 24635458
• Report Number: 3004450998-2026-00022
• Device Sequence Number: 15625507
• Product Code: NJK
• UDI-Device Identifier: 00896506002309
• UDI-Public: 896506002309
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: PMA P180007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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: WS296361
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2022
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: White