MAUDE Adverse Event Report: GYRUS ACMI, INC. 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 11/30/2023

Event Type  Injury  

Event Description

A patient underwent valve placement procedure for the treatment of emphysema.The physician successfully placed a total of two spiration valves (1x svs-v9-00, 1x svs-v7-00) in patient's left upper lung on (b)(6) 2023.A couple of hours post procedure, the patient experienced a small to moderate sized pneumothorax.The pneumothorax was noted at the post procedure chest x-ray.The patient was taken to interventional radiology for ct guided placement of a 14f left chest tube.The pneumothorax resolved without sequelae three days after event.The chest tube was removed four days after the placement procedure and the patient was released from the hospital.

Manufacturer Narrative

A total of two valves were placed in the patient (one svs-v9-00 and one svs-v7-00) for a total of two related event reports filed separately for the same patient procedure.This is report one of two associated with this event.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.H3 other text : device remains implanted in patient.

• Brand Name: VALVE IN CARTRIDGE, 9MM
• Type of Device: SPIRATION VALVE
• Manufacturer (Section D): GYRUS ACMI, INC.; 6675 185th ave ne; redmond WA 98052
• Manufacturer (Section G): GYRUS ACMI, INC.; 6675 185th ave ne; redmond WA 98052
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18402137
• MDR Text Key: 331482450
• Report Number: 3004450998-2023-00053
• 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: P180007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SVS-V9-00
• Device Lot Number: WS395832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White