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

Model Number ZEPHYR 4.0 EBV

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

Patient Problem Pleural Effusion (2010)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Pleural effusion is a known, anticipated 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), 7.0% of the zephyr valve subjects and 0% of the control subjects experienced pleural effusion during the treatment period (less than or equal to 45 days).The zephyr ebv system ifu specifically references pleural effusion as a known side effect of this procedure.The reported event aligns with the experience observed in the liberate clinical study and is an expected side effect of the zephyr valve treatment.The reported event was foreseeable and clinically acceptable in view of the expected patient benefit from the treatment.

Event Description

On (b)(6) 2021, the patient underwent a bronchoscopic lung volume reduction procedure with three zephyr valves implanted in the right upper lobe.The post-procedure x-ray showed a loculated effusion.The patient had another bronchoscopy procedure to clear secretions on (b)(6) 2021.On (b)(6) 2021, the patient had a ct scan to address the effusion and 2 chest drains were placed.After resolution, both chest drains were removed on (b)(6) 2021 and patient was discharged on (b)(6) 2021.

• 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: 11631611
• MDR Text Key: 244378375
• Report Number: 3007797756-2021-00053
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030126
• UDI-Public: (01)00811907030126(10)504877V70(17)220424
• Combination Product (y/n): N
• PMA/PMN Number: P180002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2022
• Device Model Number: ZEPHYR 4.0 EBV
• Device Catalogue Number: EBV-TS-4.0
• Device Lot Number: 504877-V7.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2020
• 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): Hospitalization; Required Intervention