MAUDE Adverse Event Report: PULMONX CORPORATION ZEPHYR ENDOBRONCHIAL VALVE

Model Number ZEPHYR 4.0 EBV

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

Patient Problems Sepsis (2067); Respiratory Failure (2484)

Event Date 01/04/2023

Event Type  Injury  

Manufacturer Narrative

Respiratory failure is an anticipated, potential side effect associated with the zephyr valve treatment (criner et al.A multicenter randomized controlled trial of zephyr endobronchial valve treatment in heterogeneous emphysema (liberate).Am j respir crit care med.2018; 198 (9): 1151-1164).In the liberate study (ide clinical study used to support pma p180002's approval), 1.6% of the zephyr valve subjects experienced respiratory failure during the treatment period ([less than or equal to 45 days).0.8% of the zephyr valve subjects and 3.2% of the control subjects experienced respiratory failure during the longer-term period from 45 days after the study procedure through 12 months post-procedure.The zephyr ebv system ifu and pulmonx training program both specifically reference respiratory failure as a known side effect of this procedure.The reported event aligns with the experience observed in the liberate clinical study and is an anticipated, potential side effect to the zephyr valve treatment.The reported event was foreseeable and clinically acceptable in view of the expected patient benefit from the treatment.Copd exacerbation is an anticipated, potential side effect associated with the zephyr valve treatment (criner et al.A multicenter randomized controlled trial of zephyr endobronchial valve treatment in heterogeneous emphysema (liberate).Am j respir crit care med.2018; 198 (9): 1151-1164).In the liberate study (ide clinical study used to support pma p180002's approval), 7.8% of the zephyr valve subjects vs.4.8% of the control subjects experienced a copd exacerbation serious adverse event (sae) during the treatment period (less than or equal to 45 days).23.0% of the zephyr valve subjects vs.30.6% of the control subjects experienced a copd exacerbation sae during the longer-term period from 45 days after the study procedure through 12 months post-procedure.The zephyr ebv system ifu and pulmonx training program both specifically reference copd exacerbation as a known, potential side effect of this procedure.The reported event aligns with the experience observed in the liberate clinical study and is an anticipated, potential side effect to the zephyr valve treatment.The reported event was foreseeable and clinically acceptable in view of the expected patient benefit from the treatment.

Event Description

The patient had bronchoscopic lung volume reduction procedures performed on (b)(6) 2022 and (b)(6) 2022 with zephyr valves implanted in the left lower lobe.The patient was admitted into the hospital due to acute hypercapnic respiratory failure on (b)(6) 2023.Additionally, the patient had copd exacerbation, right basal lung disease and streptococcus pneumoniae sepsis.The physician decided to remove all valves on (b)(6) 2023 due to repeated bronchopulmonary infections and lack of improvement with dyspnea.The patient was given cefotaxime antibiotic and non-invasive ventilation.The adverse events were resolved on (b)(6) 2023, and the patient was discharged from the hospital.

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE
• Type of Device: ENDOBRONCHIAL VALVE
• Manufacturer (Section D): PULMONX CORPORATION; 700 chesapeake drive; redwood city CA 94063
• Manufacturer Contact: mahtab fatemi ; 700 chesapeake drive; redwood city, CA 94063 ; 6504072823
• MDR Report Key: 16791814
• MDR Text Key: 313781023
• Report Number: 3007797756-2023-00069
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030119
• UDI-Public: (01)00811907030119(10)505689V70(17)230702
• 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: Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2023
• Device Model Number: ZEPHYR 4.0 EBV
• Device Catalogue Number: EBV-TS-4.0
• Device Lot Number: 505689- V7.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/02/2021
• 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