MAUDE Adverse Event Report: GYRUS ACMI, INC. VALVE IN CARTRIDGE, 7MM; SPIRATION VALVE

Model Number	SVS-V7-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Pneumonia (2011); Sepsis (2067); Loss of consciousness (2418); Respiratory Failure (2484); Respiratory Insufficiency (4462)
Date of Event	03/01/2025
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.This report is related to: (b)(6).
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 in the right lower lobe under general anesthesia on (b)(6) 2024.On (b)(6) 2025, the patient reported shortness of breath, attributed to valve displacement/migration at target locations rb6 (lot #ws388855) and rb7 (lot #ws383672).The patient went to the emergency room and was prescribed and treated with azithromycin and prednisone but was not hospitalized.A valve replacement procedure was performed on (b)(6) 2025 to address the migration and optimize treatment response.The patient continued to experience shortness of breath, requiring 5l nasal cannula (nc) oxygen to maintain stability.On (b)(6) 2025, the subject developed pneumonia, leading to hospital admission the same day.During hospitalization, the patient was treated with solu-medrol, followed by a tapering course of prednisone upon discharge.The pneumonia was associated with shortness of breath.The patient was discharged on (b)(6) 2025.On (b)(6) 2025, the subject was readmitted to the hospital after being found in a state of deep sleep.The principal investigator recommended immediate hospitalization.The patient was diagnosed with respiratory failure without mechanical ventilation and was initiated on oxygen therapy (5l).The condition was considered resolved with sequelae on (b)(6) 2025 with the patient still requiring oxygen support to maintain stability.Concurrent with this episode, the patient was diagnosed with sepsis secondary to pneumonia, with an onset date of 29-may-2025.The subject was treated with cefepime for both sepsis and pneumonia.The patient remained hospitalized until (b)(6) 2025, at which point the acute symptoms were considered resolved.The migration issue at target location rb6 (lot #ws388855) and rb7 (lot #ws383672) were addressed in complaints (b)(4).
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the final investigation.Updated fields: g1, h2, h3, h6 and h11.Based on the results of the investigation, and since the device was not returned for evaluation, the root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: VALVE IN CARTRIDGE, 7MM
• 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: 22470993
• Report Number: 3004450998-2025-00062
• Device Sequence Number: 19901782
• Product Code: NJK
• UDI-Device Identifier: 00896506002279
• UDI-Public: 896506002279
• 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
• 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
• Report Date (Section B): 10/15/2025

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-V7-00
• Device Lot Number: WS274290
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White