FDA Adverse Event Injury Summary report: N

HANAROSTENT ESO TTS FC 18 DM 6CM 180

MDR report key: 20048209 · Received August 23, 2024

Report

Report Number
2429304-2024-0000379
Event Type
Injury
Date Received
August 23, 2024
Date of Event
June 3, 2024
Report Date
August 23, 2024
Manufacturer
M.I.TECH CO LTD
Product Code
ESW
UDI-DI
08806367088208
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
VA, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOSCOPIC ULTRASOUND-GUIDED GASTROJEJUNOSTOMY FOR BENIGN GASTRIC OUTLET OBSTRUCTION (GOO): A RETROSPECTIVE ANALYSIS OF PATIENTS AND OUTCOMES". LITERATURE SUMMARY BACKGROUND AND STUDY AIMS ENDOSCOPIC ULTRASOUND-GUIDED GASTROJEJUNOSTOMY (EUS-GJ) HAS BEEN WELL UTILIZED IN TREATING MALIGNANT GASTRIC OUTLET OBSTRUCTIONS (GOO) GIVEN ITS EFFICACY AND LOWER RISK PROFILE COMPARED TO SURGERY. HOWEVER, ITS EFFICACY AND POTENTIAL FOR USE IN PATIENTS WITH BENIGN GOO WHO ARE POOR SURGICAL CANDIDATES IS NOT WELL DOCUMENTED. THE AIM OF THIS STUDY WAS TO EXAMINE THE ROLE OF EUS-GJ IN TREATMENT OF BENIGN GOO IN SELECT PATIENTS. PATIENTS AND METHODS THIS IS A SINGLE-CENTER, OPEN-LABEL, RETROSPECTIVE DESCRIPTIVE STUDY THAT INCLUDED ALL CONSECUTIVE PATIENTS UNDERGOING EUS-GJ TO TREAT BENIGN CAUSES OF GOO. DIRECT ANTEGRADE AND DIRECT RETROGRADE METHODS WERE UTILIZED. RESULTS A TOTAL OF 18 PATIENTS WERE INCLUDED, 38.9% FEMALE WITH AN AVERAGE AGE OF 63.3 YEARS. EXTRINSIC GOO WAS PRESENT IN (10 OF 18) 55.5% OF PATIENTS AND INTRINSIC ETIOLOGY WAS PRESENT IN (8 OF 18) 45.5% OF PATIENTS. TECHNICAL SUCCESS WAS ACHIEVED IN 100% (18 OF 18) PATIENTS AND CLINICAL SUCCESS WAS ACHIEVED IN 94% (17 OF 18) PATIENTS. IN TOTAL, 13 PATIENTS HAD FOLLOW-UP ENDOSCOPY, 2 PATIENTS WERE TREATED RELATIVELY RECENTLY IN TIME, 1 PATIENT WAS LOST TO FOLLOW-UP, AND 2 PATIENTS DIED OF OTHER CHRONIC ILLNESSES. STENTS REMAINED IN PLACE FOR A MEDIAN OF 286 DAYS (RANGE 88¿1444 DAYS). IN PATIENTS WHOSE STENTS WERE REMOVED, 75% (3 OF 4) HAD EXTRINSIC ETIOLOGIES OF GOO. CONCLUSIONS THIS STUDY REPORTS A FAVORABLE LONG-TERM PATENCY WITH EXCELLENT TECHNICAL AND CLINICAL SUCCESS OF EUS-GJ IN PATIENTS WITH BENIGN GOO. DESPITE THE LIMITATIONS OF SAMPLE SIZE AND RETROSPECTIVE NATURE, IT ADDS TO THE EXTREMELY LIMITED LITERATURE OF EUS-GJ IN MANAGEMENT OF PATIENTS WITH BENIGN GOO. THE FOLLOWING EVENTS HAVE BEEN REPORTED IN THE LITERATURE: INTRAOPERATIVE GASTRIC BLEEDING - RESOLVED WITH INTRAOPERATIVE EPINEPHRINE INJECTION POST-OPERATIVE GASTRIC BLEEDING - RESOLVED WITH CLIPPING AND EPINEPHRINE INJECTION POST-OPERATIVE RETROPERITONEAL HEMORRHAGE - RESOLVED WITH INTERVENTIONAL RADIOLOGY EMBOLIZATION A2: MEDIAN AGE IS 63 YEARS OLD. SINCE THE LITERATURE DESCRIBED THROUGH-THE-SCOPE (TTS) BALLOON, OLYMPUS SELECTED ECBA-18-060-180 AS A REPRESENTATIVE PRODUCT. THIS REPORT IS RELATED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6). THE DEVICE WAS NOT RETURNED. ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1581925 HANAROSTENT ESO TTS FC 18 DM 6CM 180 HANAROSTENT ESO TTS FC 18 DM 6CM 180 ESW M.I.TECH CO LTD ECBA-18-060-180 08806367088208

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Required Intervention