MAUDE Adverse Event Report: GYRUS ACMI, INC. SPIRATION VALVE

Model Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problems Hypoxia (1918); Ventilator Dependent (2395)

Event Date 06/13/2023

Event Type  Injury  

Event Description

Publication reported case study of a patient with chronic obstructive pulmonary disease (copd) that presented for computed tomography (ct) ¿ guided biopsy of the left upper lobe, with percutaneous needle trajectory hitting the left upper lobe mass and left lower lobe, resulting in the development of pneumothorax to the left lower lobe.A surgical chest tube was placed but failed to re-inflate the lungs with a water seal.The patient was transferred to the author¿s institution for further management.Patient pulmonary function tests were performed and showed low expiratory volume.The patient was determined not to be a good candidate for surgical resection.The patient underwent a video-assisted, thoracoscopic-assisted, mechanical and chemical (doxycycline) pleurodesis and endobronchial ultrasound for the staging of lung cancer.Given the patient¿s failure to respond to conservative therapy using chest tube drainage and pleurodesis, the decision was made to attempt endobronchial valve placement.Five spiration valves (valve sizes and lot numbers not identified) were placed in the left lower lobe (anterior, medial basal, lateral basal, posterior basal, and superior segments).The air leak from the chest tube completely resolved and the patient was extubated.The patient became increasingly hypoxemic and refractory to noninvasive positive-pressure ventilation.The patient was reintubated and recruitment maneuvers were used; however, the patient remained hypoxemic.Repeat bronchoscopy was performed and several mucus plugs were suctioned but failed to improve the oxygen status.Tension pneumothorax was considered, but the patient had bilateral breath sounds and was otherwise hemodynamically stable.One valve was removed from the anterior segment, resulting in marked improvement to oxygenation status with worsening of the air leak observed.The patient was transferred to the intensive care unit and intubated with a chest tube while four valves remained in place.After 24 hours, the air leak worsened, and the remaining four valves were removed.

Manufacturer Narrative

Gyrus acmi, inc.Has reviewed the event reported within publication by boulos, racha et al.¿hypoxemia after endobronchial valve deployment for persistent air leak.¿ journal of cardiothoracic and vascular anesthesia, s1053-0770(23)00227-6.3 apr.2023, doi:10.1053/j.Jvca.2023.03.036.No device malfunction was reported associated with the patient reported event of hypoxemia resulting in valve removal.The device model numbers were not specified in the publication, however the spiration valve system intended use for the treatment of air leak specifies that ¿the spiration valve is a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become air leaks following lobectomy, segmentectomy, or lung volume reduction surgery.¿ use of the spiration valve for the treatment of air leak as described in the publication is an off-label use of the device.

• Brand Name: SPIRATION VALVE
• 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: 17313407
• MDR Text Key: 319097007
• Report Number: 3004450998-2023-00044
• Device Sequence Number: 1
• Product Code: OAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H060002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN (LITERATURE)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2023
• 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; Life Threatening
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 69 KG