MAUDE Adverse Event Report: SPIRATION VALVE IN CARTRIDGE, 7MM; SPIRATION VALVE

Model Number SVS-V7-00

Device Problem Gas/Air Leak (2946)

Patient Problem Pneumothorax (2012)

Event Date 03/08/2020

Event Type  Injury  

Manufacturer Narrative

This mdr is being reported late due to delays in field reporting which prevented the complaints from being processed on time into the complaint handling system.A capa has been initiated accordingly.A total of seven valves (four svs-v7-00, two svs-v6-00 and one svs-v9-00) were placed in the patient.This report is one of seven reported events filed for the same patient.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 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.Device remains implanted.

Event Description

Patient developed a pneumothorax requiring a chest tube, post treatment with spiration valves for hyperinflation related to emphysema.Patient went on to resolve air leak, chest tube was removed, and patient was discharged home without further complications or injury.All valves (2 x svs-v6-00; 4 x svs-v7-00; 1 x svs-v9-00) were placed in left upper lobe.Pneumothorax occurred post surgery on the same day.

• Brand Name: VALVE IN CARTRIDGE, 7MM
• Type of Device: SPIRATION VALVE
• Manufacturer (Section D): SPIRATION; 6675 185th avenue ne,; redmond WA 98052
• MDR Report Key: 10280433
• MDR Text Key: 207409404
• Report Number: 3004450998-2020-00021
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00896506002279
• UDI-Public: 896506002279
• Combination Product (y/n): N
• PMA/PMN Number: PMA P180007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SVS-V7-00
• Device Lot Number: W03533-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention