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

Model Number ZEPHYR 4.0-LP EBV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumonia (2011)

Event Date 05/12/2021

Event Type  Death  

Event Description

The female patient, aged 71 years old, with a diagnosis of copd/emphysema and a baseline history of hypertension, ulcerative colitis, and fibromyalgia had been previously treated for her emphysema with placement of aspiration valves in the left upper lobe (lul).The patient underwent a bronchoscopy procedure on (b)(6) 2021 where the existing spiration valves (placed 12 months ago) were removed (for lack of effect) from the lul.Since there was also a target on the right side of the lung (little to no collateral ventilation) 5 zephyr valves were placed in the right upper and right middle lobe.The procedure was uneventful.Three days post-procedure (b)(6) 2021, the patient developed pneumonia in the left lung.The pneumonia was treated with antibiotics and nebulizer therapy.The patient had increased oxygen need and was transferred to the icu where the patient developed takotsuba cardiomyopathy.The patient did not recover and died on (b)(6) 2021.No autopsy was performed.The treating physician stated that the pneumonia was in the left lung and likely not related to the zephyr valves that were placed in the right upper and right middle lobes.

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE (EBV)
• Type of Device: ENDOBRONCHIAL VALVE
• Manufacturer (Section D): PULMONX CORPORATION; 700 chesapeake drive; redwood city CA 94063
• MDR Report Key: 17999441
• MDR Text Key: 326444784
• Report Number: 3007797756-2023-00191
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030225
• UDI-Public: (01)00811907030225(10)505064V71(17)220616
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2022
• Device Model Number: ZEPHYR 4.0-LP EBV
• Device Catalogue Number: EBV-TS-4.0-LP
• Device Lot Number: 505064-V7.1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2020
• 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): Death; Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female