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	Unspecified Infection (1930); Respiratory Failure (2484)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent bronchoscopic lung volume reduction (blvr) procedure, wherein 2 valves were implanted to treat severe emphysema.Then 2 days after, the patient underwent subsequent valve removal of both valves due to acute on chronic respiratory failure with hypoxia and hypercapnia.The patient was then started on bilevel positive airway pressure (bipap) and was given antibiotics and steroids.Additionally, there was a report of mild infection through bronchoalveolar lavage (bal) sampling which was done during valve removal.The patient was treated with antibiotics, and the issues were resolved without further sequelae.
Additional Manufacturer Narrative
The reports of the following patient identifiers are linked: (b)(6).The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device was not returned for evaluation; therefore, a definitive root cause could not be determined.The most probable cause was not established; the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information was received from the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information for the manufacturing date.Updated field: h4.
Event or Problem Description
No additional information was received from the customer.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA ; 5082077661
• MDR Report Key: 21573301
• Report Number: 3004450998-2025-00019
• Device Sequence Number: 15688596
• Product Code: NJK
• UDI-Device Identifier: 00896506002279
• UDI-Public: 896506002279
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2025

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: W S479927
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 04/16/2025; 05/14/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/15/2025; 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic