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

Model Number IBV-V7

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

This reported event involved ibv-v7, the model number sold outside of the united states.The event occurred in australia.Product lot number was not provided.Additional follow-up with a hospital physician who had discussed the case with the attending physician provided further clarification related to movement of the valve.The physician communicated that the ibv-v7 spiration valve was no longer sealing the airway.Therefore, the attending physician decided to remove the ibv-v7 and replace with the next available size (ibv-v9 spiration valve).He also clarified that the ibv-v7 did not migrate, but may have had movement due to the angled location of the valve.H6 investigation finding code 4256.H3 other text : user discarded device.

Event Description

The patient had reportedly undergone a prior valve placement procedure for the treatment of emphysema using valves from a different manufacturer.The date of the prior procedure and the number of valves placed at that time is unknown.After a period of unknown time, the patient coughed out the other manufacturer¿s valves.The quantity of valves that were coughed out was not provided.The physician made the decision to replace the other manufacturer¿s valves with spiration valves.The date of the spiration valve placement procedure and the quantity of spiration valves placed was not provided.The physician noted a good patient outcome following the spiration valve placement procedure.Weeks later (date or specific timeframe could not be provided), the patient returned to the hospital, and it was found the patient¿s lung was re-inflated.Physician investigation observed the ibv-v7 valve had moved.The lobe location was not provided.During the investigation, the physician also observed that there was a leak from one edge of the valve.The physician decided to remove the valve using forceps in accordance with the product instructions for use.No complications or valve damage was reported during the ibv-v7 valve removal process.The ibv-v7 was subsequently replaced with an ibv-v9 valve.Placement of the ibv-v9 achieved good results; however, the physician noted there was difficulty placing the ibv-v9 due to the angle it had to be placed and the bronchoscope had to be flexed to correctly place the valve.The physician noted that the membrane was peeled away from the valve struts of the ibv-v7 valve that was removed.No further complications were noted as of the date of this report.This event is being reported for the observed leak resulting in the re-inflated lung and the membrane that was peeled away from the valve struts.

• Brand Name: VALVE IN CARTRIDGE, 7MM
• Type of Device: SPIRATION VALVE
• MDR Report Key: 18718094
• MDR Text Key: 336527120
• Report Number: 3004450998-2024-00005
• Device Sequence Number: 1
• Product Code: NJK
• Combination Product (y/n): N
• PMA/PMN Number: P180007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IBV-V7
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2024
• 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; Hospitalization