FDA Adverse Event Injury Summary report: N

EVIS EXERA III BRONCHOVIDEOSCOPE

MDR report key: 13666899 · Received March 4, 2022

Report

Report Number
2951238-2022-00344
Event Type
Injury
Date Received
March 4, 2022
Report Date
March 4, 2022
Manufacturer
OLYMPUS MEDICAL SYSTEMS CORP.
Product Code
EOQ
UDI-DI
04953170402470
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
WI, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

IT IS REPORTED IN THE LITERATURE TITLED ¿TRANSBRONCHIAL LUNG CRYOBIOPSY IS SAFE AND EFFECTIVE FOR DIAGNOSING ACUTELY ILL HOSPITALIZED PATIENTS WITH NEW DIFFUSE PARENCHYMAL LUNG DISEASE¿, PATIENTS EXPERIENCED ADVERSE EVENTS REQUIRING INTERVENTION DURING OR AFTER TRANSBRONCHIAL LUNG CRYOBIOPSY (TBLC) USING ONE OF TWO OLYMPUS SCOPES. STUDY AIM: COMPARISON OF TBLC FOR HOSPITALIZED AND OUTPATIENTS AND PROVIDE THE SAFETY AND DIAGNOSTIC YIELDS IN THESE POPULATIONS. STUDY METHOD: DEMOGRAPHIC DATA, PULMONARY FUNCTION VALUES, CHEST IMAGING PATTERN, PROCEDURAL INFORMATION, AND DIAGNOSIS WERE RECORDED FROM ENROLLED PATIENTS. COMPLICATIONS FROM THE PROCEDURE WERE THE PRIMARY OUTCOMES AND DIAGNOSTIC YIELD WAS THE SECONDARY OUTCOME. RESULTS: 77 PATIENTS (N = 22 HOSPITALIZED VS N = 55 OUTPATIENT) UNDERWENT TBLC DURING THE STUDY PERIOD. COMPARING ADVERSE EVENTS BETWEEN HOSPITALIZED AND OUTPATIENTS REVEALED NO STATISTICALLY SIGNIFICANT DIFFERENCES IN PNEUMOTHORAX (9%, N = 2 VS 5%,N = 3), TUBE THORACOSTOMY PLACEMENT (5%, N = 1 VS 2%, N = 1 ), GRADE 2 BLEEDING (9%, N = 2 VS 0%, N = 0), ESCALATION IN LEVEL OF CARE (5%, N= 1 VS 0%, N=0), 30-DAY MORTALITY (9%, N=2 VS 2%, N= 1), AND 60-DAY MORTALITY (9%, N=2 VS 4%, N=2) (P > 0.05 FOR ALL). NO DEATHS WERE ATTRIBUTED TO THE PROCEDURE. 95% OF CASES RECEIVED A MULTIDISCIPLINARY CONFERENCE DIAGNOSIS (HOSPITALIZED 100%, N=22 VS OUTPATIENTS 93%, N=51, P=0.32). CONCLUSIONS: OUR EXPERIENCE SUPPORTS THAT TBLC MAY BE A SAFE AND EFFECTIVE MODALITY FOR ACUTELY ILL-HOSPITALIZED PATIENTS WITH DPLD. FURTHER EFFORTS TO ENHANCE PROCEDURAL SAFETY AND TO DETERMINE THE IMPACT OF AN EXPEDITED TISSUE DIAGNOSIS ON PATIENT OUTCOMES ARE NEEDED. COMPLICATIONS FROM THE PROCEDURE WERE SIMILAR IN BOTH GROUPS. PNEUMOTHORAX OCCURRED IN 6% (N=5) OF PATIENTS (N= 2, 9% INPATIENT VS N= 3, 5% OUTPATIENT) (P = 0.6202). CHEST TUBE PLACEMENT WAS REQUIRED IN 3% (N=2) OF PATIENTS (N=1, 5% INPATIENT VS N=1, 2% OUTPATIENT) (P=0.4925). ALL CHEST TUBES WERE REMOVED WITHIN 24 H. GRADE 2 BLEEDING, AS PER CONSENSUS DEFINITION, OCCURRED IN 3% (N = 2) OF PATIENTS, BOTH OF WHOM WERE INPATIENTS (N=2, 9% INPATIENT), AND OF WHICH ONE, ALTHOUGH HEMODYNAMICALLY STABLE, WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR CLOSER MONITORING AS PER THE PRIMARY CARE TEAM¿S DECISION (N=1, 2% OF PATIENTS, 5% OF INPATIENTS, TRANSFER IN LEVEL OF CARE). FOR ALL OTHER PATIENTS, ONLY GRADE 1 BLEEDING OCCURRED, WHICH DID NOT REQUIRE ANY INTERVENTION ASIDE FROM BRIEF SUCTIONING WITH OBSERVATION UNTIL HEMOSTASIS WAS CONFIRMED. ALL CAUSE 30-DAY AND 60-DAY MORTALITY WERE SIMILAR BETWEEN THE TWO GROUPS AND NO DEATHS WERE DIRECTLY ATTRIBUTABLE TO THE PROCEDURE. FOR THE INPATIENT MORTALITIES, ONE PATIENT DIED TEN DAYS AFTER THE PROCEDURE, WHICH WAS ONE WEEK AFTER DISCHARGE FROM THE HOSPITAL, DUE TO OUT OF HOSPITAL CARDIAC ARREST WITH VENTRICULAR FIBRILLATION ON INITIAL HYPOXEMIC RESPIRATORY FAILURE DUE TO ARDS FROM COVID-19 PNEUMONIA 29 DAYS AFTER THE PROCEDURE. THERE WAS NO REPORT OF OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS LITERATURE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE BF-1TH90 USED IN PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE BF-XT190 USED IN PROCEDURES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1564294 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-XT190 04953170402470

Patients

Seq Age Sex Outcome Treatment
1 Unknown Hospitalization| O| R