FDA Adverse Event Injury Summary report: N

EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

MDR report key: 14016276 · Received April 5, 2022

Report

Report Number
2951238-2022-00366
Event Type
Injury
Date Received
April 5, 2022
Date of Event
September 4, 2020
Report Date
April 5, 2022
Manufacturer
OLYMPUS MEDICAL SYSTEMS CORP.
Product Code
ODG
UDI-DI
04953170341809
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MA, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

IT IS REPORTED IN THE LITERATURE TITLED ¿A COMPARISON OF CLINICAL OUTCOMES AND COST UTILITY AMONG LAPAROSCOPY, ENTEROSCOPY, AND TEMPORARY GASTRIC ACCESS ASSISTED ERCP IN PATIENTS WITH ROUX EN Y GASTRIC BYPASS ANATOMY,¿ PATIENTS EXPERIENCED ADVERSE EVENTS IN THREE STUDY GROUPS USING DIFFERENT OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE DAE GROUP AES (DEVICE: OLYMPUS SINGLE OR DOUBLE BALLOON DUODENOSCOPE-MODEL NOT SPECIFIED). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE LA-ERCP GROUP AES (DEVICE: OLYMPUS THERAPEUTIC DUODENOSCOPE-MODEL NOT SPECIFIED). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE GATE GROUP AES (DEVICE: GF-UCT180 OR TGF-UC180J). BACKGROUND AND AIMS: GASTRIC ACCESS TEMPORARY FOR ENDOSCOPY (GATE), ALSO KNOWN AS EUS-DIRECTED TRANSGASTRIC ERCP (EDGE), HAS DEMONSTRATED ADVANTAGES OVER DEVICE-ASSISTED ENTEROSCOPY (DAE) AND LAPAROSCOPIC-ASSISTED ERCP (LA-ERCP) FOR PATIENTS WITH ROUX-EN-Y GASTRIC BYPASS (RYGB) ANATOMY. WE AIMED TO DIRECTLY COMPARE CLINICAL OUTCOMES AND COST UTILITY AMONG THE THREE ERCP MODALITIES METHOD: PATIENTS WITH RYGB ANATOMY WHO HAD DAE, LA-ERCP, OR GATE FROM 2009 TO 2019 AT 2 TERTIARY CENTERS WERE INCLUDED IN OUR REVIEW. WE MEASURED OUTCOMES IN THREE AREAS: SUCCESS RATE, POST-PROCEDURAL ADVERSE EVENTS (AES) AND HOSPITALIZATION, AND COST UTILITY PER MEDICARE/MEDICAID INSURANCE PAYMENTS. RESULTS: S COHORT TOTAL 130 PATIENTS (70 UNDERWENT DAE, 42 LA-ERCP, AND 18 GATE). SUCCESS RATE DAE WAS SUCCESSFUL IN 59% OF PATIENTS, COMPARED TO SUCCESS RATES OF 98 AND 100% FOR LA-ERCP AND GATE, RESPECTIVELY (P <¿0.001). FOR DAE, 62% OF UNSUCCESSFUL CASES REQUIRED RESCUE THERAPY. ADVERSE EVENTS AND HOSPITALIZATION PATIENTS WHO UNDERWENT GATE HAD THE LOWEST RATE OF HOSPITALIZATION POST PROCEDURE (44% VS. 77% AND 100% FOR DAE AND LA-ERCP, RESPECTIVELY, P¿<¿0.01) AND SPENT THE LEAST AMOUNT OF TIME HOSPITALIZED (MEDIAN TIME 0 DAYS VS 2 AND 3 DAYS FOR DAE AND LA-ERCP, RESPECTIVELY, P¿<¿0.0001). GATE HAD LOWER AE RATES THAN LA-ERCP (6 VS 31%, P¿=¿0.046), AND BOTH HAD SIMILAR RATES TO DAE. COST UTILITY LA-ERCP CARRIED THE HIGHEST TOTAL PROCEDURAL AND HOSPITALIZATION COST PER MEDICARE/ MEDICAID INSURANCE PAYMENTS (MEDIAN PAYMENT DIFFERENCE OF $9.7 K VS GATE AND $7.9 K VS DAE, P¿<¿0.01 FOR BOTH). PROCEDURAL AND HOSPITALIZATION COSTS WERE SIMILAR BETWEEN GATE AND DAE (P¿=¿0.76). CONCLUSIONS: GATE IS A SAFE MODALITY FOR ERCP WITH HIGH SUCCESS RATES IN RYGB PATIENTS AND EXHIBITS THE LOWEST HOSPITALIZATION TIME AND RATE OF ADVERSE EVENTS WHEN COMPARED TO DAE AND LA-ERCP. GATE IS SIMILAR TO DAE FROM A COST UTILITY APPROACH, AND BOTH ARE LESS COSTLY THAN LA-ERCP. ONE PATIENT IN THE GATE GROUP EXPERIENCED GASTRIC BLEEDING DUE TO STENT DISLODGMENT THAT WAS TREATED ENDOSCOPICALLY WITH NO SURGICAL INTERVENTION REQUIRED. THERE IS NO REPORT OF OLYMPUS DEVICE MALFUNCTION DESCRIBED IN THIS STUDY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
907061 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170341809

Patients

Seq Age Sex Outcome Treatment
1 Unknown Other| R