MAUDE Adverse Event Report: GYRUS ACML, 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); Pneumothorax (2012)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via social media (facebook) that after having two valves placed about a year ago, the patient underwent a computed tomography (ct) scan which confirmed the valves had shifted.The two valves were removed from the left lower lobe and four valves were placed in the patient's upper lobe.The following day, the patient¿s lung collapsed, and a chest tube was inserted.Shortly after, the patient¿s lung ripped, requiring a second chest tube placement.The patient developed an infection and was admitted to the intensive care unit (icu).A fifth valve was implanted in the lower lobe, and the patient's lung collapsed again.The patient remained in the icu for a total of 16 days.The patient was discharged with one chest tube, which has since been removed.
Additional Manufacturer Narrative
This report is related to the following patient identifiers: (b)(6).Since the device is unknown, olympus has selected "svs-v7-00" as a representative product.For additional information, please refer to the following link for the facebook post: https://www.Facebook.Com/742865081174811/posts/1125187362942579?comment_id=2057053261438325.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 the field performance of this device.

• Brand Name: VALVE IN CARTRIDGE, 7MM
• Common Device Name: SPIRATION VALVE
• Manufacturer (Section D): GYRUS ACML, 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: 21596426
• Report Number: 3004450998-2025-00024
• Device Sequence Number: 12981213
• Product Code: NJK
• UDI-Device Identifier: 00896506002279
• UDI-Public: 896506002279
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PMA P180007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 03/13/2025
• 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 Sex: Female