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

Model Number ZEPHYR 5.5 EBV

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

Patient Problem Pleural Effusion (2010)

Event Date 05/20/2020

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 ((b)(6)).Am j respir crit care med.2018; 198 (9): 1151-1164).In the (b)(6) 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 (b)(6) 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

Patient underwent a bronchoscopic lung volume reduction (blvr) procedure with zephyr valves placed on (b)(6) 2020.The patient had mild pleural effusion which started on (b)(6) 2020.The patient was hospitalized on (b)(6) 2020 and received an additional bronchoscopy on (b)(6) 2020.The pleural effusion was treated with puncture based on sonography and resolved on (b)(6) 2020.The patient was discharged from the hospital on (b)(6) 2020.

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE (EBV)
• Type of Device: ENDOBRONCHIAL VALVE
• Manufacturer (Section D): PULMONX CORPORATION; 700 chesapeake drive; redwood city, ca
• MDR Report Key: 10112832
• MDR Text Key: 194313655
• Report Number: 3007797756-2020-00123
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030317
• UDI-Public: (01)00811907030317(10)504601V70(17)211028
• 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,foreig
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2021
• Device Model Number: ZEPHYR 5.5 EBV
• Device Catalogue Number: EBV-TS-5.5
• Device Lot Number: 504601-V7.0
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2019
• 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
• Patient Age: 75 YR