FDA Adverse Event Death Summary report: N

ZEPHYR ENDOBRONCHIAL VALVE (EBV)

MDR report key: 21853844 · Received April 17, 2025

Report

Report Number
3007797756-2025-00014
Event Type
Death
Date Received
April 17, 2025
Date of Event
March 17, 2025
Report Date
April 16, 2025
Manufacturer
PULMONX CORPORATION
Product Code
NJK
UDI-DI
00811907030157
PMA / PMN Number
P180002
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
003

Narratives

Description of Event or Problem · 0

THIS 81-YEAR-OLD MALE PATIENT SUFFERING FROM SEVERE COPD SINCE 2011 WITH COR PULMONALE DIAGNOSED IN (B)(6) 2024, WAS TREATED ON (B)(6) 2024 WITH 3 ZEPHYR VALVES PLACED IN THE RUL (RBI: 4.0 LP, RB2: 4.0, AND RB3: 4.0). THEN, THE PATIENT WAS DISCHARGED ON (B)(6) 2024 AND HAD NO PROBLEMS FOR 2 MONTHS. ON (B)(6) 2025, THE PATIENT EXPERIENCED ARTHRALGIA AND ANOREXIA WHILE BEING UNWELL SINCE A FEW DAYS. ON (B)(6) IN THE MORNING, HE WAS TRANSPORTED TO EMERGENCY CARE BECAUSE HE WAS FOUND UNABLE TO MOVE BY THE FAMILY. ON ARRIVAL THE PATIENT WAS RECEIVING ANTIBIOTIC (ERYTHROMYCIN) FOR PNEUMONIA, AND MEDICATION FOR COPD (ON SL OXYGEN) AND CARDIAC INSUFFICIENCY (FUROSEMIDE). HE WAS HYPOTENSIVE, WITH TYPE 2 RESPIRATORY FAILURE. AFTER TREATMENT WITH IV FLUIDS, A CHEST CT WAS PERFORMED AND SHOWED AN EXTENSIVE INFILTRATIVE SHADOW IN THE RLL. BLOOD TESTS SHOWED AN ELEVATED INFLAMMATORY RESPONSE. A COMMUNITY-ACQUIRED PNEUMONIA OF THE RLL WAS CONFIRMED (STREPTOCOCCUS PNEUMONIA). THUS, A SEPTIC SHOCK ASSOCIATED WITH THE ONGOING PNEUMONIA WAS CONSIDERED. THE PATIENT WENT INTO A CARDIOPULMONARY ARREST DURING IMAGING SESSION, AND - ALTHOUGH HIS OWN HEARTBEAT RESUMES AFTER ROUTINE CARDIOPULMONARY RESUSCITATION AND THE PATIENT RETURNED TO CONSCIOUSNESS - BLOOD PRESSURE REMAINED LOW AND CIRCULATION PARAMETERS VERY UNSTABLE. AFTER FAMILY CONSULTATION, THE DECISION WAS MADE NOT TO RESUSCITATE THE PATIENT AT THE TIME OF CARDIAC ARREST. DEATH WAS CONFIRMED AT THE EMERGENCY ROOM (B)(6) 2025). IN SUMMARY, THIS SEVERE COPD PATIENT WITH CARDIAC COMPLICATION (COR PULMONALE), DIED 3 MONTHS AFTER BL VR (RUL) WITH ZEPHYR® VALVES FROM A SEPTIC SHOCK RELATED TO PNEUMONIA IN THE RLL. THE DEATH IS NOT RELATED TO THE PROCEDURE, WHICH WAS PERFORMED 3 MONTHS EARLIER, AND UNLIKELY RELATED TO THE VALVES WHICH WERE NOT IMPLANTED IN THE INFECTED LOBE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
113952 ZEPHYR ENDOBRONCHIAL VALVE (EBV) ENDOBRONCHIAL VALVE NJK PULMONX CORPORATION ZEPHYR 4.0 EBV 506847-V7.0 00811907030157

Patients

Seq Age Sex Outcome Treatment
1 81 YR Male Death