FDA Adverse Event Injury Summary report: N

EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE

MDR report key: 20311368 · Received September 26, 2024

Report

Report Number
2429304-2024-0000421
Event Type
Injury
Date Received
September 26, 2024
Date of Event
April 30, 2024
Report Date
September 26, 2024
Manufacturer
SHIRAKAWA OLYMPUS CO., LTD.
Product Code
PSV
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
NC, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOBRONCHIAL ULTRASOUND GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION AND NEXT GENERATION SEQUENCING YIELDS." ABSTRACT: PURPOSE: THE USE OF ENDOBRONCHIAL ULTRASOUND (EBUS) IS STANDARD PRACTICE FOR LUNG CANCER DIAGNOSIS AND STAGING. NEXT GENERATION SEQUENCING (NGS) FOR DETECTION OF GENETIC ALTERATIONS IS RECOMMENDED IN ADVANCED, NON-SQUAMOUS, NON-SMALL CELL LUNG CANCER (NSCLC). EXISTING PROTOCOLS FOR NGS TESTING ARE MINIMAL AND REPORTED YIELDS VARY. THIS STUDY AIMED TO DETERMINE THE YIELD OF EBUS SAMPLES OBTAINED FOR NGS USING A SAMPLING PROTOCOL AT OUR INSTITUTION AND ASSESS PREDICTIVE FACTORS TO FORM COLLECTION PROTOCOLS. METHODS: WE REVIEWED EBUS BRONCHOSCOPIES FROM 2016 TO 2021 WITH NON-SQUAMOUS NSCLC DIAGNOSES. FOR TARGET LESIONS SUSPECTED TO BE MALIGNANT, THE SAMPLING PROTOCOL WAS: (A) TWO SLIDES FOR ON-SITE EVALUATION, (B) THREE TO FIVE FNE NEEDLE ASPIRATIONS RINSED INTO SALINE FOR IMMUNOHISTOCHEMICAL STAINING AND IN-HOUSE MOLECULAR MARKERS, AND (C) ADDITIONAL THREE TO FIVE RINSES FOR NGS. SUFFICIENCY FOR NGS PROCESSING WAS DETERMINED BY THE PATHOLOGY DEPARTMENT. RESULTS: TWO HUNDRED AND SEVENTY-EIGHT NON-SQUAMOUS NSCLC SAMPLES WERE OBTAINED BY EBUS (205 ADENOCARCINOMA; 73 NOT OTHERWISE SPECIFIED). EBUS WAS PERFORMED UNDER GENERAL ANESTHESIA IN 75.5% OF CASES. THE OVERALL SAMPLE ADEQUACY FOR NGS TESTING WAS 57.5%. HIGHER ADEQUACY RATES WERE OBSERVED WHEN PROTOCOL WAS ADHERED TO 66.0% VERSUS 37.2% (P<0.001). THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE BASED ON THE SIZE OF THE LESION OR LOCATION OF THE SAMPLE. THERE WERE 7 (2.5%) PROCEDURE RELATED COMPLICATIONS, WHICH INCLUDED HYPOXIA REQUIRING ADMISSION (0.4%, N=1), TRANSIENT BRONCHOSPASM OR DESATURATION (1.1%, N=3), OVERALL POOR TOLERANCE OF THE PROCEDURE (0.7%, N=2), AND OTHER COMPLICATIONS NOT SPECIFIED (0.4%, N=1). THERE WAS NO REPORTS OF PNEUMOTHORAX, HEMOPTYSIS, PNEUMONIA, HYPOTENSION, ARRHYTHMIA, OR DEATH. CONCLUSION: WHEN A PROTOCOL OF THREE TO FIVE DEDICATED NEEDLE RINSES FOR NGS WAS FOLLOWED, WE NEARLY DOUBLED OUR SAMPLE ADEQUACY RATE FOR NSG AS COMPARED TO STANDARD CARE. STUDIES ARE NEEDED TO DETERMINE THE IDEAL COLLECTION AND PROCESSING MODALITY TO PRESERVE TISSUE SAMPLES FOR GENETIC SEQUENCING. TYPE OF SERIOUS ADVERSE EVENTS/NUMBER OF PATIENTS HYPOXIA REQUIRING ADMISSION (1 PATIENT).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2239871 EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC160F-OL8

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Hospitalization UNKNOWN 21G NEEDLE