MAUDE Adverse Event Report: ZEPHYR ENDOBRONCHIAL VALVE (EBV)

Model Number ZEPHYR 5.5-LP EBV

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

Patient Problems Pleural Effusion (2010); Pneumothorax (2012)

Event Date 07/15/2020

Event Type  Injury  

Manufacturer Narrative

Pneumothorax is the most common 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).Targeted lobar deflation likely causes inflation of the ipsilateral lobe, which can result in a tear of the already compromised parenchymal tissue of the emphysematous ipsilateral lobe, resulting in a pneumothorax (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), 26.6% of the zephyr valve subjects experienced a pneumothorax in the treatment period ([less than or equal to 45 days).These were managed using standard of care procedures as per previously published guidelines (valipour, arschang, et al.Respiration 87.6 (2014): 513-521).In 17.4% of the events, the pneumothorax resolved without any additional intervention with subjects under careful observation.In over half the events (56.5%), the pneumothorax was managed with a chest-tube only.An additional 13% of the events were managed with a chest-tube and the temporary removal of one or more valves, while another 13% of the events were managed with a chest-tube and removal of all the implanted valves.Upon successful resolution of the pneumothorax, removed valves can be replaced.Patients that experienced a pneumothorax experienced clinical benefits of the zephyr valve treatment that were similar to the benefits experienced by patients who did not have a pneumothorax.The zephyr ebv system ifu and pulmonx training program both specifically reference pneumothorax as a known side effect of this procedure and the published guidelines (valipour, arschang, et al."expert statement: pneumothorax associated with endoscopic valve therapy for emphysema-potential mechanisms, treatment algorithm, and case examples." respiration 87.6 (2014): 513-521).The reported event aligns with the experience observed in the liberate clinical study and is an expected side effect to the zephyr valve treatment.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) 2020, the patient developed an asymptomatic, moderate in size pneumothorax after 4 zephyr valves were placed in the left lower lobe.Patient had no significant complications during the implantation process.Post-procedure chest x-ray showed no pneumothorax on (b)(6) 2020.Second chest x ray one hour later showed trace left apical pneumothorax with small to moderate.An 18 f (pig tail) chest tube was placed.Subsequent chest x-rays showed no pneumothorax and the event was deemed resolved on (b)(6) 2020.The chest tube was removed on (b)(6) 2020.The patient returned to the clinic for a follow-up on (b)(6) 2020.The patient has done well since discharge and stated that he is not using supplemental oxygen, had no cough, mucus production, fevers, chills or night sweats, chest pain or hemoptysis.Small to moderate-sized left-sided pleural effusion with associated compressive atelectasis was noted on the chest x-rays on (b)(6) 2020 and on (b)(6) 2020.The treating physician stated that minimal pleural effusion is an expected consequence related to total atelectasis, it's not considered to be a complication, and no treatment was needed.

Manufacturer Narrative

The date of event was corrected in this follow-up report.

Manufacturer Narrative

The date of event was corrected in this follow-up report.

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE (EBV)
• Type of Device: ENDOBRONCHIAL VALVE
• MDR Report Key: 10388319
• MDR Text Key: 207117855
• Report Number: 3007797756-2020-00180
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030423
• UDI-Public: (01)00811907030423(10)504550V70(17)210924
• 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,Followup,Followup
• Report Date: 07/17/2020

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: 09/24/2021
• Device Model Number: ZEPHYR 5.5-LP EBV
• Device Catalogue Number: EBV-TS-5.5-LP
• Device Lot Number: 504550-V7.0
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 07/17/2020; 07/17/2020
• Supplement Dates FDA Received: 08/10/2020; 08/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2019
• 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: 69 YR
• Patient Weight: 76