BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE (EBV)

    MDR report key: 12720533 · Received October 29, 2021

    Report

    Report Number
    3007797756-2021-00308
    Event Type
    Death
    Date Received
    October 29, 2021
    Date of Event
    August 18, 2021
    Report Date
    January 27, 2022
    Manufacturer
    PULMONX CORPORATION
    Product Code
    NJK
    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

    THE FULL NARRATIVE FROM THE TREATING PHYSICIAN IS PROVIDED BELOW. THE PATIENT WAS A 71 YEAR-OLD MALE WITH A HISTORY OF SEVERE COPD, HYPERTENSION, AND HYPERKERATOSIS LENTICULARIS PERSTANS (HLP). HE WAS EVALUATED FOR, AND TREATED WITH ZEPHYR VALVES ON (B)(6) 2021 WITH PLACEMENT OF 6 VALVES ON THE LEFT UPPER LOBE (LUL). POST-PROCEDURE COURSE WAS UNEVENTFUL AND PATIENT WAS DISCHARGED ON (B)(6) 2021 WITH NO COMPLICATIONS ATTENDANT TO THE PROCEDURE OR HIS HOSPITAL STAY. THE PATIENT HAD TESTED NEGATIVE FOR COVID-19 ON (B)(6) 2021, BUT TESTED POSITIVE ON (B)(6) 2021. PER THE PATIENT'S WIFE AND SISTER-IN-LAW, PATIENT HAD IMPROVED EASE-OF-BREATHING TILL THE MORNING OF 15 AUG 2021 WHEN HE REPORTEDLY NOTED WORSENING SENSE-OF-UNEASE BUT WITHOUT RESPIRATORY DISTRESS. EMS WAS CONTACTED AND THEY HAD DIFFICULTY REMOVING THEIR STRETCHER AND THEN CAME TO HIS SIDE AND NOTED FINGERTIP OXIMETRY READINGS IN THE MID-70'S. HIS WIFE SPOKE SEVERAL TIMES WITH EMS WARNING THEM, AS THE TREATING PHYSICIAN HAD CAUTIONED HER AND PATIENT TO DO IF HE SHOULD BECOME SHORT-OF-BREATH OR HAVE CHEST PAIN, THAT HE MAY HAVE A LEFT-SIDED PNEUMOTHORAX AND THAT HE WOULD NEED A CHEST TUBE - A NEEDLE DECOMPRESSION WAS NOT PERFORMED. INSTEAD, EMS PLACED HIM ON THE STRETCHER AND THEN TOOK HIM TO THE AMBULANCE WHERE OROTRACHEAL INTUBATION (OT) MAY HAVE BEEN UNSUCCESSFULLY ATTEMPTED LEADING TO NASOTRACHEAL INTUBATION (NT). SUBSEQUENT TO HIS NT PLACEMENT HE BECAME CYANOTIC WITH REPORTED ABSENT BILATERAL BREATH SOUNDS. HE WAS BROUGHT TO THE ED WHERE HE WAS PERSISTENTLY HYPOXEMIC. HIS NT WAS REPLACED BY AN OT TUBE OUT OF CONCERN FOR ESOPHAGEAL INTUBATION WITH AN IMPROVEMENT IN HIS SPO2 BUT THIS WAS THEN ACCOMPANIED BY ASYSTOLIC ARREST. A LEFT LUNG NEEDLE DECOMPRESSION WAS PERFORMED BUT SERIAL ASYSTOLIC ARRESTS (CIRCA 35 MINUTES) ENSUED WITH EVENTUAL RETURN OF SPONTANEOUS CIRCULATION (ROSC). HIS SUBSEQUENT CLINICAL COURSE WAS MARKED BY FURTHER CLINICAL DETERIORATION WITH ASSOCIATED COVID-ATTRIBUTED ARDS, SEVERE SEPSIS WITH SEPTIC SHOCK, AND SUSPECTED ANOXIC BRAIN INJURY. AFTER FAMILY CONSULTATIONS, HE WAS TRANSITIONED FIRST TO DNR-CCA AND THE COMFORT CARE STATUS WITH WITHDRAWAL OF TECHNICAL LIFE SUPPORT FROM 0700 ON (B)(6) 2021. THE PATIENT DIED ON (B)(6) 2021. THE PRIMARY CAUSE OF DEATH WAS DOCUMENTED AS CARDIOPULMONARY ARREST DUE TO COVID-19 PNEUMONIA. THERE WAS NO DOCUMENTATION ON ANY RELATIONSHIP OF THIS EVENT TO THE VALVES AND THE TREATING PHYSICIAN CONCURS WITH THE ASSESSMENT THAT HIS RESPIRATORY FAILURE WITH SUBSEQUENT CARDIOPULMONARY ARREST AND ARDS WAS LIKELY COVID-19 ATTRIBUTABLE. NO AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 1

    THE PATIENT WAS A (B)(6) YEAR-OLD MALE WITH A HISTORY OF SEVERE COPD, HYPERTENSION AND HYPERKERATOSIS LENTICULARIS PERSTANS (HLP). PATIENT WAS EVALUATED AND TREATED WITH ZEPHYR VALVES ON (B)(6) 2021. THE PATIENT WAS DISCHARGED ON (B)(6) 2021. PER THE PATIENT'S WIFE AND SISTER-IN-LAW, THE PATIENT HAD IMPROVED EASE-OF-BREATHING. SUBSEQUENTLY THE PATIENT REPORTEDLY NOTED WORSENING SENSE-OF-UNEASE BUT WITHOUT RESPIRATORY DISTRESS. EMS WAS CONTACTED AND THEY HAD DIFFICULTY REMOVING THEIR STRETCHER AND THEN CAME TO HIS SIDE AND NOTED FINGERTIP OXIMETRY READINGS IN THE MID-70'S. HIS WIFE SPOKE SEVERAL TIMES WITH EMS WARNING THEM, AS THE PHYSICIAN HAD CAUTIONED HER AND PATIENT TO DO IF HE SHOULD BECOME SHORT-OF-BREATH OR HAVE CHEST PAIN, THAT HE MAY HAVE A LEFT-SIDED PNEUMOTHORAX AND THAT HE WOULD NEED A CHEST TUBE - A NEEDLE DECOMPRESSION WAS NOT PERFORMED. EMS PLACED HIM ON THE STRETCHER AND THEN TOOK HIM TO THE AMBULANCE WHERE OT INTUBATION MAY HAVE BEEN UNSUCCESSFULLY ATTEMPTED LEADING TO NT INTUBATION. SUBSEQUENT TO HIS NT PLACEMENT HE BECAME CYANOTIC WITH REPORTED ABSENT BILATERAL BREATH SOUNDS. HE WAS BROUGHT TO THE ED WHERE HE WAS PERSISTENTLY HYPOXEMIC. HIS NT WAS REPLACED BY AN OT TUBE OUT OF CONCERN FOR ESOPHAGEAL INTUBATION WITH AN IMPROVEMENT IN HIS SPO2 BUT THIS WAS THEN ACCOMPANIED BY ASYSTOLIC ARREST. A LEFT LUNG NEEDLE DECOMPRESSION WAS PERFORMED BUT SERIAL ASYSTOLIC ARRESTS (CIRCA 35 MINUTES) ENSUED WITH EVENTUAL RETURN OF SPONTANEOUS CIRCULATION (ROSC). HIS SUBSEQUENT CLINICAL COURSE WAS MARKED BY FURTHER CLINICAL DETERIORATION. AFTER FAMILY CONSULTATIONS HE WAS TRANSITIONED FIRST TO DNR-CCA AND THE COMFORT CARE STATUS WITH WITHDRAWAL OF TECHNICAL LIFE SUPPORT ON (B)(6) 2021. THE PATIENT DIED ON (B)(6) 2021. THE CAUSE OF DEATH AND OTHER DETAILS ARE STILL PENDING RECEIPT OF FOLLOW-UP INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER ADDITIONAL INFORMATION IS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619419 ZEPHYR ENDOBRONCHIAL VALVE (EBV) ENDOBRONCHIAL VALVE NJK PULMONX CORPORATION ZEPHYR 4.0-LP EBV 505277-V7.1

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| D