MAUDE Adverse Event Report: VALVE IN CARTRIDGE, 6MM; SPIRATION VALVE

Model Number	SVS-V6-00
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Valves not returned as they remain implanted.A total of two valves were placed in the patient (1 x svs-v6-00 and 1 x svs-v9-00), for a total of two related event reports filed separately associated with the same patient procedure.Pneumothorax is the most common device related serious adverse event that is associated with the spira20677759tion 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 a 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 controlled clinical 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.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 controlled clinical 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 remains implanted.
Event or Problem Description
The patient was being treated for severe emphysematous lungs.Patient had two previous elvr procedures where another manufacturer¿s valves were placed in the rul.In the third procedure, the patient underwent removal of two previously placed valves and placement of two spiration valves, one 6mm and one 9mm.Pneumothorax occurred immediately after the procedure in the lobe adjacent to the target lobe.A chest tube was placed, and the pneumothorax resolved after eight days.

• Brand Name: VALVE IN CARTRIDGE, 6MM
• Common Device Name: SPIRATION VALVE
• MDR Report Key: 11017100
• Report Number: 3004450998-2020-00043
• Device Sequence Number: 4241490
• Product Code: NJK
• UDI-Device Identifier: 00896506002293
• UDI-Public: 896506002293
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P180007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

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: W03461-01
• 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: 11/10/2020
• Initial Report FDA Received Date: 12/16/2020
• 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