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 Codes	Abscess (1690); Pneumonia (2011)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A total of three valves were placed in the patient (one svs-v6-00 and two svs-v7-00) for a total of three related event reports filed separately for the same patient procedure.This is report three of three associated with the event.
Event or Problem Description
Patient underwent endobronchial valve placement procedure for the treatment of emphysema on (b)(6) 2023.One 7mm valve (svs-v7-00) was placed at lb9+10 and a second 7mm valve (svs-v7-00) was placed at lb7+8.A third 7 mm valve (svs-v7-00) was initially placed at lb6, however following visualization for placement and fit according to the labeling, the valve was removed and replaced with a 6mm valve (svs-v6-00) at lb6.Again, following visualization for fit, the 6mm valve was removed and another 6mm valve (svs-v6-00) was placed at lb6 and remained in the patient.A total of three spiration valves remained placed in the patient's left lower lobe (one 7mm at lb9+10, one 7mm at lb7+8 and one 6mm at lb6).Approximately one year later (b)(6) 2024, the patient was hospitalized for pulmonary abscess in the left lower lung (i.E., in the valve treated lobe).The patient was treated with antibiotics and computed tomography of the thorax was obtained.Surgical intervention to remove the three valves from the left lower lobe occurred on (b)(6)2024.The pulmonary abscess resolved without sequelae, and the patient was discharged on (b)(6) 2024.The event was reported to be related to the device resulting from post obstructive pneumonia.

• 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: 20153314
• Report Number: 3004450998-2024-00039
• Device Sequence Number: 15529210
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: SVS-V6-00
• Device Lot Number: WS257309
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2022
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: White