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

Model Number	SVS-V6-00
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Hemoptysis (1887); Unspecified Infection (1930); Pneumonia (2011)
Date of Event	05/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent spiration valve placement procedure for the treatment of emphysema.Two valves were placed, one svs-v9-00 and one svs-v6-00.Patient was reported to have done well post procedure.On (b)(6) 2024, approximately four years post valve placement procedure, the patient presented with hemoptysis.A bronchoscopic procedure was subsequently performed to evaluate the patient.During the bronchoscopic procedure, the valve membranes were observed to be detached from the strut and an abscess with evidence of infection surrounding the valves was observed.The source of the abscess was noted to be a post obstructive infection.Cultures of the area were performed; however results were not provided.The patient was diagnosed with pneumonia in the valve treated lobe.The two valves were removed (date of removal unknown).Patient was hospitalized for 2 weeks and was released to home on a course of antibiotics.In the six to twelve months prior to the event, the patient was reported to have had a history of recurrent respiratory infections and had been hospitalized prior to the valve removal procedure.
Additional Manufacturer Narrative
Two spiration valves were placed in the patient.Two event reports were filed separately, one for each device.This is report two of two for the related event.

• 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 01581 ; 5082077661
• MDR Report Key: 19464357
• Report Number: 3004450998-2024-00022
• Device Sequence Number: 20688977
• Product Code: NJK
• UDI-Device Identifier: 00896506002293
• UDI-Public: 896506002293
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P180007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/04/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SVS-V6-00
• Device Lot Number: W03452-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2024
• 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: 05/05/2024
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2009
• 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: Unknown