FDA Adverse Event Injury Summary report: N

ZEPHYR ENDOBRONCHIAL VALVE

MDR report key: 21919885 · Received April 28, 2025

Report

Report Number
MW5169567
Event Type
Injury
Date Received
April 28, 2025
Date of Event
August 10, 2023
Report Date
April 22, 2025
Manufacturer
PULMONX, CORP.
Product Code
NJK
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OK, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND
Health Professional
*

Narratives

Description of Event or Problem · 0

MY HUSBAND HAD THE ZEPHYR VALVES IMPLANTED STARTING (B)(6) 2023. WITHIN A WEEK OR SO HE STARTED TO DEVELOP INCREASED CONGESTION, WHEEZING. I CALLED THE DOCTOR AND RECEIVED MEDICATION WHICH DECREASED THE SYMPTOMS. FOR SEVERAL MONTHS THIS WAS A LINGERING ISSUE. ON SUBSEQUENT VISITS TO THE SPECIALIST I ASKED IF IT WAS POSSIBLE THAT HIS BODY MIGHT BE REJECTING THESE IMPLANTS AND WE WERE TOLD "IT DOESN'T WORK LIKE THAT". AS AN RN, I KNOW THE BODY CAN REJECT "FOREIGN OBJECTS" OF ALL KIND. HE WAS SHORT OF BREATH AND SIMPLY DID NOT FEEL WELL. SCANS AND X-RAYS NOTED GRANULOMAS AND INFECTIVE PROCESSES. FINALLY, THE VALVES WERE TAKEN OUT ON (B)(6) 2024. AS A RESULT OF THE VALVES HAVING BEEN PLACED HIS PULMONARY HYPERTENSION HAS GREATLY INCREASED AND HAS WORSENED SIGNIFICANTLY. PERHAPS A CLOSER FOLLOWING OF PATIENTS WITH PH IS IN ORDER, OR EVEN A PATIENT BEING TOLD THAT "YOUR BODY CAN REJECT THESE VALVES" MIGHT BE IN ORDER. ALSO, ONE HAD CLOSED OFF, ONE HAD MIGRATED AND ONE WAS SOMEWHAT FUNCTIONAL. HE WAS FOUND TO HAVE GRANULOMAS THAT HAD FORMED, SOME HAD RESOLVED AND THE OVERALL LOOK OF HIS LUNGS WAS A CLEAR INDICATION THAT THE VALVES DID NOT HELP. I FEEL THAT SOMEONE NEEDS TO KNOW AND PERHAPS MORE SCRUTINY PRIOR TO IMPLANTING THEM MIGHT SAVE SOMEONE THE LONG-LASTING NEGATIVE EFFECTS HE IS SUFFERING NOW. THANK YOU. MANY SCANS WERE DONE AND I CAN GET THAT INFO TO YOU IF YOU REQUEST AND WANT TO READ THE REPORTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
481835 ZEPHYR ENDOBRONCHIAL VALVE VALVE, PULMONARY NJK PULMONX, CORP.

Patients

Seq Age Sex Outcome Treatment
1 70 YR Male Hospitalization| O ALBUTEROL INHALER.| ASA.| CQ 10.| ELDERBERRY.| EZETIMIBE.| PROBIOTIC.| ROSUVASTATIN.| SENNA.| SERTRALINE.| SILDENAFIL.| TRILOGY INHALER.