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

Model Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problem Respiratory Failure (2484)

Event Type  Injury  

Manufacturer Narrative

Event was reported in singh h, kurman js, jani c, abdalla m, depaul b, benn bs.Off-label use of intrabronchial valves for persistent air leak is safe and effective: a retrospective case analysis.J thorac dis.2022 dec;14(12):4725-4732.Doi: 10.21037/jtd-22-824.Pmid: 36647468; pmcid: pmc9840033.Reported event is associated with the off-label use of the spiration valve.Device not returned to manufacturer.

Event Description

Publication reported one patient with bilateral persistent air leaks (pal) secondary to penetrating trauma was deemed not to be a surgical candidate at the time of ibv evaluation.The patient was treated off-label and five (5) svs valves were placed.This patient developed progressive hypoxic respiratory failure shortly after insertion of the valves, necessitating removal of two (2) of the valves.It was reported the patient had a chest tube (21 days) that was not successfully removed post valve placement, requiring a thoracotomy and wedge resection for repair of the persistent air leak.No device malfunction associated with this event was reported.

• Brand Name: VALVE IN CARTRIDGE
• 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: 16616070
• MDR Text Key: 312013887
• Report Number: 3004450998-2023-00031
• 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: Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2023
• 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