MAUDE Adverse Event Report: PULMONX CORPORATION ZEPHYR ENDOBRONCHIAL VALVE (EBV)

Model Number ZEPHYR 4.0 EBV

Device Problem Migration (4003)

Patient Problems Dyspnea (1816); Foreign Body In Patient (2687)

Event Date 06/05/2019

Event Type  malfunction  

Event Description

The patient presented in the emergency department with shortness of breath two weeks after a bronchoscopic lung volume reduction (blvr) procedure with zephyr valves.He was evaluated for pneumothorax.Radiology determined that there was no pneumothorax present, however the occluded lobe had expanded.In the bronchoscopy suite, the lower right lobe of the patient was examined and the valve from the superior segment was deemed missing.The valve had migrated and was found in the right upper lobe inverted and rotated.The valve was removed without incident and a 5.5 valve was placed in the superior segment.The patient had almost immediate atelectasis, and had a ct scan and x-rays.The patient's shortness of breath had resolved, and he was discharged from the hospital on the following day.

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE (EBV)
• Type of Device: ENDOBRONCHIAL VALVE
• Manufacturer (Section D): PULMONX CORPORATION; 700 chesapeake drive; redwood city CA 94063
• Manufacturer Contact: leland keyt ; 700 chesapeake drive; redwood city, CA 94063 ; 6502160144
• MDR Report Key: 8764587
• MDR Text Key: 150149368
• Report Number: 3007797756-2019-00069
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030126
• UDI-Public: (01)00811907030126(10)504176V70(17)201102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2020
• Device Model Number: ZEPHYR 4.0 EBV
• Device Catalogue Number: EBV-TS-4.0
• Device Lot Number: 504176-V7.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2018
• 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): Hospitalization; Required Intervention