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

Model Number	HUS-V7
Health Effect - Clinical Code	Pneumonia (2011)
Date of Event	12/17/2022
Type of Reportable Event	Death
Event or Problem Description
Four spiration valves were placed in the upper right lobe of the lung on (b)(6) 2022.The patient developed pneumonia/ild flare on post-operative day 1.There was no pneumonia in the segment treated with the valves.The patient was treated with antibiotics, steroids, and o2 support.The patient was subsequently placed in hospice care and died on (b)(6) 2023.
Additional Manufacturer Narrative
Four spiration valves (3x hus-v9, 1x hus-v7) were placed in the patient.A total of four event reports were filed separately, one report for each device.The implanting physician stated the valves performed as intended and the adverse event was directly related to the procedure as pneumonia and ild flare are known complications of bronchoscopy.Device not returned to manufacturer.

• 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: 16206766
• Report Number: 3004450998-2023-00007
• Device Sequence Number: 5454673
• Product Code: OAZ
• UDI-Device Identifier: 00896506002101
• UDI-Public: 00896506002101
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: HDE H060002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/19/2023

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: HUS-V7
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Death
• Patient Sex: Unknown