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

Model Number ZEPHYR 4.0-LP EBV

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

Patient Problems Anemia (1706); Dyspnea (1816); Low Oxygen Saturation (2477)

Event Date 12/30/2021

Event Type  Death  

Manufacturer Narrative

Pulmonx has reached out to the physician and will submit a follow-up once the physician's narrative has been received.

Event Description

The patient was undergoing 2-stage zephyr valve treatment and had their valve placement procedure #2 on (b)(6) 2021.The patient experienced a copd exacerbation and was hospitalized on (b)(6) 2021 for hemolytic anemia and dyspnea increase.The patient was treated with tazocolline and ciflox.On (b)(6) 2022, the patient was desaturating.The desaturation was initially well controlled with oxygen; however the patient later experienced desaturation and unconsciousness and passed away on (b)(6) 2022.

Event Description

The patient was undergoing 2-stage zephyr valve treatment and had their valve placement procedure #2 on (b)(6) 2021.The patient experienced a copd exacerbation and was hospitalized on (b)(6) 2021 for hemolytic anemia and dyspnea increase.The patient was treated with tazocolline and ciflox.On (b)(6) 2022, the patient was desaturating.The desaturation was initially well controlled with oxygen; however the patient later experienced desaturation and unconsciousness and passed away on (b)(6) 2022.From the physician: "both the copd exacerbation and hemolytic anemia were thought to have led to this subjects death, although cardiogenic participation in this subject who was also suffering valvular and ischemic cardiopathy cannot be eliminated.".

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE (EBV)
• 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: 13671271
• MDR Text Key: 286638082
• Report Number: 3007797756-2022-00051
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030218
• UDI-Public: (01)00811907030218(10)505144V71(17)220813
• 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
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2022
• Device Model Number: ZEPHYR 4.0-LP EBV
• Device Catalogue Number: EBV-TS-4.0-LP
• Device Lot Number: 505144-V7.1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2020
• 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): Death; Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male