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

Model Number SVS-V7-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Date 09/17/2019

Event Type  Injury  

Manufacturer Narrative

Pneumothorax is the most common device related serious adverse event that is associated with the spiration valve system.In the improve 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 et al.Improving lung function in severe heterogenous emphysema with the spiration® valve system (emprove): a multicenter, open-label, randomized, controlled trial.Am j respir crit care med.2019 jul 31.Doi: 10.1164/rccm.201902-0383oc.[epub ahead of print]).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 et al.Expert statement: pneumothorax associated with endoscopic valve therapy for emphysema ¿ potential mechanisms, treatment algorithm and case examples.Respiration 2014; 8: 513-521), subjects with pneumothorax events experienced clinical benefits similar to that in subjects without pneumothorax events (criner et al.Ajrccm 2019 jul 31.Doi: 10.1164/rccm.201902-0383oc.[epub ahead of print].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 Description

After placement of two valves for severe emphysema, the patient had a pneumothorax.A chest tube was placed.There was no other patient injury.The patient remained in the hospital and had the valves removed three days later.The air leak did not resolve over the next 12 days; patient had a pleurodesis procedure to resolve pneumothorax.

• Brand Name: VALVE IN CARTRIDGE, 7MM
• Type of Device: SPIRATION VALVE
• Manufacturer (Section D): SPIRATION; 6675 185th avenue ne,; redmond WA 98052
• Manufacturer Contact: cyndy adams ; 6675 185th ave ne; redmond, WA 98052 ; 4256365450
• MDR Report Key: 9205950
• MDR Text Key: 163064298
• Report Number: 2951238-2019-01157
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00896506002279
• UDI-Public: 896506002279
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PMA P180007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2019

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
• Device Operator: Health Professional
• Device Model Number: SVS-V7-00
• Device Lot Number: W03042-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/17/2019
• 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): Hospitalization; Required Intervention