MAUDE Adverse Event Report: GYRUS ACMI, INC. VALVE IN CARTRIDGE, 5MM; SPIRATION VALVE

Model Number	SVS-V5-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Four spiration valves (1x svs-v7-00, 2x svs-v9-00, 1x svs-v5-00) were placed in the patient.A total of four event reports were filed separately, one report for each device.This is the second of four reports.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.
Event or Problem Description
Patient had four spiration valves placed on (b)(6) 23.On (b)(6) 23 patient developed a small left apical pneumothorax, which resolved without intervention within two days.Seven days after surgery patient developed a new large pneumothorax with atelectasis of the left lung and rightward mediastinal shift.Chest tube was placed and after subsequent x-ray, medical team inserted an interim left-sided pleural-based pigtail catheter in situ.Hospital stay was prolonged.On (b)(6) 23, doctor stated that patient had no air leak in the inferior chest tube, had decreased diminishing fluid, and that chest x-ray was improved.Doctor stated that the patient was overall improved.Patient was released on (b)(6) 23 with heimlich valve in place.Pneumothorax resolved, and patient returned to have the heimlich valve removed about a week later, (b)(6) 23.Spiration valves remain in place.

• Brand Name: VALVE IN CARTRIDGE, 5MM
• 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: 16500064
• Report Number: 3004450998-2023-00020
• Device Sequence Number: 12294440
• Product Code: NJK
• UDI-Device Identifier: 00896506002286
• UDI-Public: 00896506002286
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2023

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-V5-00
• Device Lot Number: WS265232
• 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: 02/06/2023
• Initial Report FDA Received Date: 03/07/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Male