MAUDE Adverse Event Report: GYRUS ACMI, INC. VALVE IN CARTRIDGE, 5MM; SPIRATION VALVE 5MM

Model Number	SVS-V5-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chronic Obstructive Pulmonary Disease (COPD) (2237); Respiratory Insufficiency (4462)
Date of Event	12/05/2024
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)(4).
Event or Problem Description
The patient underwent multiple aspiration valve placement in the left lower lobe under general anesthesia.One 9 mm valve was placed in lb6, one 7 mm valve was placed in lb8, one 7 mm valve was placed in lb9, one 5 mm valve was placed in lb10, one 7 mm valve was placed in lb7, and lastly, one 5 mm was placed in lb10.A few months post procedure the patient had an acute chronic obstructive pulmonary disease exacerbation that the reporter considered life threatening and required hospitalization for four days where the patient was treated with iv antibiotics.The patient was later discharged to home with augmentin and a prednisone taper.The event was considered resolved without sequalae.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.The device was not returned to olympus for inspection and the reported failure was not confirmed.The most probable cause of the complaint is categorized as; cause not established, which is 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 received from customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information from the customer and updates on the approved final investigation.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
Additional information was received from the customer that within 24-48 hours of discharge, the patient's symptoms started again and worsened over a few days.Patient continued to complain of dyspnea with exertion.Patient was noted to have oxygen saturation at around 85% on room air.Patient also endorses to some mild orthopnea.In the emergency department, received solu-medrol 125 mg iv, lasix 20 mg once, and albuterol and duoneb treatment.Labs show mildly elevated d-dimer during which follow-up cta showed no pe but showed emphysematous changes with some mild mucus plugging.With treatment, saturations did improve.Heart rate improved and much of vitals were improved.

• Brand Name: VALVE IN CARTRIDGE, 5MM
• Common Device Name: SPIRATION VALVE 5MM
• 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: 21182049
• Report Number: 3004450998-2025-00012
• Device Sequence Number: 21013041
• Product Code: NJK
• UDI-Device Identifier: 00896506002286
• UDI-Public: 00896506002286
• 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
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2025

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-V5-00
• Device Lot Number: WS380883
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 04/22/2025; 05/28/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 05/21/2025; 06/24/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AIRWAY SIZING KIT W S454763.; BALLOON CATHETER 39K.; CATHETER AND LOADER KIT W S456733.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White