MAUDE Adverse Event Report: PULMONX CORPORATION ZEPHYR ENDOBRONCHIAL VALVE

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Respiratory Tract Infection (2420)

Event Date 09/11/2019

Event Type  Death  

Manufacturer Narrative

The clinical investigation is still on-going.The exact date of the patient's death has not been confirmed.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 (b)(6)-year-old patient had a bronchoscopic lung volume reduction procedure and zephyr valves were placed in the right upper lobe (rul) and right middle lobe (rml).At the time of the initial procedure, mucoid secretions were found which were sent for culture.At the time of the procedure, the patient had no clinical signs of infection.He stayed in the hospital for 3 days per protocol and was discharged from the hospital on (b)(6) 2019.He was doing well at the time of discharge without any signs of distress or abnormal radiological findings.Radiological findings showed atelectatic changes to his right upper lobe (rul).The respiratory culture that was obtained returned positive for staphylococcus aureus.The patient was seen by the physician in follow-up the following week and stated he had hemoptysis and was prescribed doxycycline.The patient presented to the emergency room on (b)(6) 2019 with generalized malaise and generalized joint pain.A cat scan was done which reportedly demonstrated an abscess on the right upper lobe (rul).The clinical confirmation of an abscess is still being reviewed by another physician expert and has not yet been confirmed.The patient was admitted and started on antibiotics.His cat scan was reviewed, and given the persistence of the reported abscess and his elevated white blood count on (b)(6) 2019 the physician decided to remove one zephyr valve (4.0-lp ebv) placed in the posterior segment of the right upper lobe (rul) which was believed to be the valve that lead into the general region of the reported abscess.Abundant purulent secretions were obtained and cultures demonstrated presence of acinetobacter.The patient had some clinical improvement, continued to receive intravenous antibiotics, and then developed acute abdominal pain.The patient presented with a perforated viscus's, underwent exploratory laparotomy on (b)(6) 2019, and was found to have a perforated duodenal ulcer with pancreatic abscess and peritonitis.His duodenum was repaired and a bypass procedure was needed.Unfortunately the patient continued to have clinical deterioration, was required to have further surgical procedures which were unsuccessful in repairing his severe intra-abdominal pathology.The patient's relatives opted for palliative care and hospice care and he was discharged to hospice where he passed.

Manufacturer Narrative

Multiple attempts have been made to collect additional information about this event.Unfortunately, no additional information has been provided from the site after several months of communication attempts.If information is received at a later date, follow-up reports will be submitted.

• 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: 9242235
• MDR Text Key: 163887057
• Report Number: 3007797756-2019-00162
• Device Sequence Number: 1
• Product Code: NJK
• 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
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 74