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

Model Number	SVS-V9-00
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
1 of 2 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 multiple spiration valve placement in the right lower lobe under general anesthesia.One 7mm valve was placed in rb8, one 7mm valve was placed in rb9, one 7mm valve was placed in rba10, one 9mm valve was placed in rb 7, and lastly, an additional 9 mm valve was placed in rb6.Post procedure the patient was monitored in a hospital bed and had a chest x-ray performed.On (b)(6) 2025, the patient experienced shortness of breath and was treated in the emergency room with azithromycin and prednisone and discharged.The event was considered related to the device due to valve migration of the 9mm valves in rb6 and rb7.On (b)(6) 2025, the 9mm valves in rb6 and rb7 were removed due to valve migration and replaced.
Additional Manufacturer Narrative
The device was not returned to olympus for inspection.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: 25036574
• Report Number: 3004450998-2026-00034
• Device Sequence Number: 9039441
• Product Code: NJK
• UDI-Device Identifier: 00896506002309
• UDI-Public: 896506002309
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: PMA P180007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SVS-V9-00
• Device Lot Number: WS388855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2023
• 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: AIRWAY SIZING KIT #WS454763; CATHETER LOADER KIT #WS456688; CATHETER LOADER KIT #WS4567331; DISPOSABLE BALLOON CATHETER #44K
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White