MAUDE Adverse Event Report: SPIRATION VALVE IN CARTRIDGE, 9MM; SPIRATION VALVE

Model Number SVS-V9-00

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

Patient Problem Pneumothorax (2012)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

After chest tube was placed to treat the pneumothorax, the patient's breathing and chest pains was resolved.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 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

Svs-v9-00 was used during a procedure where a patient developed a pneumothorax after the procedure was completed.Update per investigation tab: svs-v9-00 spiration valve.Patient developed a pneumothorax(collapsed lung)after the spiration valve- svs-v9-00 was used during the procedure.2 spiration valves from the same lot number where used to treat lobe, for complete inclusion of the upper lobe.As the patient was waking up developed chest pains and difficulty breathing.A chest x-ray was performed and found the patient had developed a pneumothorax.A chest tube was placed to treat the pneumothorax.After inserting the tube the chest pains and breathing difficulty was resolved.Patient was than transferred to pacu for normal recovery.(b)(4).

• Brand Name: VALVE IN CARTRIDGE, 9MM
• 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: 9507886
• MDR Text Key: 189610207
• Report Number: 3004450998-2019-00008
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00896506002309
• UDI-Public: 896506002309
• 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: Physician
• Type of Report: Initial
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: SVS-V9-00
• Device Lot Number: W03463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2019
• Date Device Manufactured: 09/23/2019
• 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