MAUDE Adverse Event Report: VALVE IN CARTRIDGE, 5MM; SPIRATION VALVE 5MM

Model Number	SVS-V5-00
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	07/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Three valves and lot numbers were reported, for a total of three related reports filed separately for the same event.It is not known whether the valves were removed or whether additional valves were involved.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.Disposition of valves is unknown.
Event or Problem Description
Patient was treated for emphysema with the spiration valve.Patient experienced a pneumothorax.Two svs-v7-00 valve lots and one svs-v5-00 lot were used.The total number of valves placed is unknown at the time of this report.

• Brand Name: VALVE IN CARTRIDGE, 5MM
• Common Device Name: SPIRATION VALVE 5MM
• MDR Report Key: 12485594
• Report Number: 3004450998-2021-00024
• Device Sequence Number: 4264496
• Product Code: NJK
• UDI-Device Identifier: 00896506002286
• UDI-Public: 00896506002286
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2021

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-V5-00
• Device Lot Number: W03032-01
• 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: 08/19/2021
• Initial Report FDA Received Date: 09/16/2021
• 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: Required Intervention