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 Code	Pneumonia (2011)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A total of four valves were placed in patient (1x svs-v7-00, 2x svs-v9-00, and 1x svs-v6-00) for a total of four related event reports filed separately and associated with the same patient procedure.
Event or Problem Description
Patient reported that they had four spiration valves placed (1x svs-v7-00, 2x svs-v9-00, and 1x svs-v6-00) for the treatment of emphysema (left lung).Patient reported chest trauma and shortness of breath following a car accident approximately five months after the placement procedure.Patient contacted healthcare provider and returned for subsequent medical evaluation.Chest x-ray and ct scan performed indicated that the valves remained in place.Clinician performed a follow-up bronchoscopy and confirmed all four valves were in the original position and no valves exhibited any damage.Clinician indicated there was tissue granulation and clinician opted to remove all four valves.Patient returned to the hospital after the bronchoscopy for valve removal and was admitted for treatment of pneumonia.
Additional Manufacturer Narrative
A total of four valves were placed in patient (1x svs-v7-00, 2x svs-v9-00, and 1x svs-v6-00) for a total of four related event reports filed separately and associated with the same patient procedure.
Event or Problem Description
Patient reported that they had four spiration valves placed (1x svs-v7-00, 2x svs-v9-00, and 1x svs-v6-00) for the treatment of emphysema (left lung).Patient reported chest trauma and shortness of breath following a car accident approximately five months after the placement procedure.Patient contacted healthcare provider and returned for subsequent medical evaluation.Chest x-ray and ct scan performed indicated that the valves remained in place.Clinician performed a follow-up bronchoscopy and confirmed all four valves were in the original position and no valves exhibited any damage.Clinician indicated there was tissue granulation and clinician opted to remove all four valves.Patient returned to the hospital after the bronchoscopy for valve removal and was admitted for treatment of pneumonia.

• Brand Name: VALVE IN CARTRIDGE, 6MM
• Common Device Name: SPIRATION VALVE
• Manufacturer (Section D): GYRUS ACMI, INC; 6675 185th avenue ne,; redmond WA 98052
• Manufacturer Contact: sophia rubalcaba ; 6675 185th ave ne; redmond, WA 98052 ; 4256365470
• MDR Report Key: 12849625
• Report Number: 3004450998-2021-00028
• Device Sequence Number: 17295514
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2021

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: W03452-01
• 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: 10/21/2021
• Initial Report FDA Received Date: 11/19/2021
• 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; Required Intervention
• Patient Sex: Unknown