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	Pneumothorax (2012)
Date of Event	10/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Five spiration valves were placed in the patient.Five event reports were filed separately, one for each device.This is report one of five for the reported pneumothorax event.Pneumothorax is the most common device related serious adverse event that is associated with the spiration valve system.In the emprove study, the incidence of serious pneumothorax was 14.2%, with over 75% of the serious pneumothorax events occurring within the first 3 days post-procedure.Early-onset pneumothorax in the treatment group likely resulted from lung conformation changes due to acute reduction in lung volume by valve therapy, triggering rapid expansion of the ipsilateral non-targeted lobe leading to pneumothorax.(criner gj, delage a, voelker k, et al.Improving lung function in severe heterogenous emphysema with the spiration® valve system (emprove): a multicenter, open-label, randomized control trial.Am j respir crit care med.2019;200(11):1354-1362.Doi:10.1164/rccm.201902-0383oc).However, it should be noted that pneumothorax events are also recognized as an indicator of successful target lobe occlusion and when managed according to published expert guidelines (valipour a, slebos dj, de oliveira hg, et al.Expert statement: pneumothorax associated with endoscopic valve therapy for emphysema -- potential mechanisms, treatment algorithm and case examples.Respiration 2004 2014; 87(6): 513-521.Doi:10.1159/000360642), subjects with pneumothorax events experienced clinical benefits similar to that in subjects without pneumothorax events (criner gj, delage a, voelker k, et al.Improving lung function in severe heterogenous emphysema with the spiration valve system (emprove).A multicenter, open-label, randomized control trial.Am j respir crit care med.2019;200(11):1354-1362.Doi:10.1164/rccm.201902-0383oc).The reported event aligns with the experience in the emprove clinical trial and is an expected adverse event associated with the spiration valve system.H3 other text: device discarded after removal.Not returned to manufacturer.
Event or Problem Description
A patient underwent valve placement procedure for the treatment of emphysema on (b)(6) 2023.The physician placed 1x 6mm, 1x 7mm valve, and 1x 9mm valve.One 9mm valve was removed due to fit and replaced with a 7mm valve.Subsequently two additional 9mm valves were placed.In total five valves were placed in the right upper lobe.After a four day stay, the patient was released from hospital with no complications at the time of discharge.Ten days after valve placement procedure on (b)(6) 2023), the patient was admitted to a different hospital.Chest x-ray was taken, ct scan was performed, and pneumothorax was confirmed a chest tube was inserted to treat the pneumothorax with suction.Twenty-four days after initial valve placement on (b)(6) 2023), all five valves were removed due to continuing air leaks.During the removal procedure, an abundance of mucous was observed and the patient was treated with antibiotics for suspected pneumonia.The patient was discharged from hospital four days after valve removal on (b)(6) 2023) with heimlich valve in place for pneumothorax and on antibiotics to treat suspected pneumonia.Culture results were requested but to date no pneumonia has been confirmed.There was no reported device malfunction.
Event or Problem Description
Patient's culture test results came back negative for pneumonia.Patient was seen by physician 28 days post hospital discharge ((b)(6) 2023).There was no evidence of an air leak.Computed tomography (ct) confirmed pneumothorax resolution.The heimlich valve (not a gyrus product) was left in place but was subsequently removed 5 days later ((b)(6) 2023).

• 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: 18145703
• Report Number: 3004450998-2023-00048
• Device Sequence Number: 7016266
• 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
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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: SVS-V6-00
• Device Lot Number: WS261272
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White