MAUDE Adverse Event Report: PULMONX CORPORATION ZEPHYR ENDOBRONCHIAL VALVE

Model Number ZEPHYR 4.0 EBV

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abscess (1690); Pleural Effusion (2010); Pneumonia (2011)

Event Date 09/21/2019

Event Type  Injury  

Manufacturer Narrative

The clinical investigation is still on-going.A follow-up report will be submitted once additional information is obtained and the clinical investigation is complete.

Event Description

On (b)(6) 2019 the patient had a bronchoscopic lung volume reduction procedure and seven zephyr valves (five 4.0 ebvs, one 4.0-lp ebv, and one 5.5 ebv) were placed.The patient was doing fine.The doctor's office had a difficult time in locating the patient for follow-up appointments after the procedure.On (b)(6) 2019 the patient reported to a community hospital with pneumonia (i.E., clinical finding of post obstructive pneumonia), possible sepsis, and lung abscess.The on-call physician at the community hospital called the treating physician and they decided to remove the valves.Due to the presence of blood thinners, the physicians decided to wait to remove the valves.On (b)(6) 2019, all valves were removed.On (b)(6) 2019, the patient was still on a ventilator and had purulent secretions, and the physician performed a tracheostomy and placed a tracheostomy tube.Per an update received on oct.18, 2019, the patient is doing much better, is off the ventilator and x-rays show improvement.The physician is planning to remove the tracheostomy tube on (b)(6) 2019, and is planning to discharge the patient after a few more days of continuous improvement.

Event Description

On (b)(6) 2019 the patient had a bronchoscopic lung volume reduction procedure and seven zephyr valves (five 4.0 ebvs, one 4.0-lp ebv, and one 5.5 ebv) were placed.The patient was doing fine.The doctor's office had a difficult time in locating the patient for follow-up appointments after the procedure.On (b)(6) 2019, the patient was admitted to a different (b)(6) hospital with shortness of breath, fever, chills, sputum, and cavitary pneumonia.The patient received iv antibiotics.He declined and had to be intubated, ventilated, and was transferred to icu.The on-call physician at the (b)(6) hospital called the treating physician and they decided to remove the valves on (b)(6) 2019.Due to the presence of blood thinners, the physicians decided to wait to remove the valves.When the valves were removed, they showed purulent discharge on them.The patient also had aspiration pneumonia and pleural effusion.He had a chest tube placed draining 2 liters of fluid and had empyema.The chest tube was removed.The patient had a tracheostomy and a peg (percutaneous endoscopic gastrostomy).The patient was then approved for transfer to long-term acute care on (b)(6) 2019.Per an update received on (b)(6) 2019, the patient was doing much better, was off the ventilator, and x-rays showed improvement.The physician had planned to remove the tracheostomy tube on (b)(6)2019, and had planned to discharge the patient after a few more days of continuous improvement.Per an update received on (b)(6) 2020, the treating physician and doctor's office had been trying to reach the patient for further follow-up, however, they were unsuccessful.They did receive notice from a family member that the patient was now in a (b)(6) facility but did not disclose the reason for this.

Manufacturer Narrative

Pneumonia 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), 0.8% of the zephyr valve subjects vs.0% of the control subjects experienced a pneumonia serious adverse event (sae) during the treatment period (less than or equal to 45 days).5.7% of the zephyr valve subjects vs.8.1% of the control subjects experienced a pneumonia 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 pneumonia as a known, potential side effect of this procedure and provide guidelines for monitoring.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.

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE
• Type of Device: ENDOBRONCHIAL VALVE
• Manufacturer (Section D): PULMONX CORPORATION; 700 chesapeake drive; redwood city CA 94063
• MDR Report Key: 9216524
• MDR Text Key: 170119934
• Report Number: 3007797756-2019-00151
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030126
• UDI-Public: (01)00811907030126(10)504149V70(17)201011
• 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
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2020
• Device Model Number: ZEPHYR 4.0 EBV
• Device Catalogue Number: EBV-TS-4.0
• Device Lot Number: 504149-V7.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR