MAUDE Adverse Event Report: GYRUS ACMI, INC. VALVE IN CARTRIDGE, 6MM; SPIRATION VALVE

Model Number	SVS-V6-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is linked to the following patient identifiers: (b)(6) 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
A patient underwent valve placement procedure for the treatment of emphysema on (b)(6) 2024.A total of four aspiration valves were placed in the right lower lobe; two 7mm (svs-v7-00) valves were placed one each at rb7+8 and rb6, one 9mm (svs-v9-00) was placed at rb9+10 and the fourth valve (svs-v6-00) was placed at a variant location.The patient had a post procedure x-ray and was admitted to a monitored hospital bed.On (b)(6) 2024, the patient experienced a pneumothorax in the valve treated lobe.An 18f chest tube was placed in interventional radiology under computed tomography (ct) guidance in the right lung.The patient remained in the hospital and the event was reported to be on-going but patient condition stable at the time of this report.The physician indicated that the event was related to the devices but not the procedure.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: h6.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.

• Brand Name: VALVE IN CARTRIDGE, 6MM
• 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 ; 5082077661
• MDR Report Key: 20867969
• Report Number: 3004450998-2024-10001
• Device Sequence Number: 8591942
• Product Code: NJK
• UDI-Device Identifier: 00896506002293
• UDI-Public: 896506002293
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P180007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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-V6-00
• Device Lot Number: WS456735
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White