ORISE GEL

Description of Event or Problem

BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AN ORISE GEL THROUGH THE ARTICLE, ASGE COLON AND RECTUM IIIENDOSCOPIC AND HISTOLOGIC FINDINGS AFTERENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WITHA NOVEL SUBMUCOSAL INJECTION SOLUTION, BY STAVROPOULOS S. ET AL. PER THE ARTICLE, DATA WAS COLLECTED FROM AN ESD DATABASE OF OVER 1000 ESD PROCEDURES. THE AUTHORS ABSTRACTED ESDS IN WHICH ORISE GEL WAS USED AND WHICH HAD SUBSEQUENT SURVEILLANCE ENDOSCOPY. THE STUDY GROUP WAS RESTRICTED TO COLON LESIONS SINCE THE CONCERNS REPORTED WERE MAINLY IN COLON RESECTIONS. MALIGNANT LESIONS WERE EXCLUDED AS OUR INVESTIGATION OF ORISE GEL MIMICKING NEOPLASTIC CHANGES COULD BE CONFOUNDED BY RECURRENT/RESIDUAL MALIGNANCY. 37 LESIONS RECEIVED ESG. THE AUTHORS DID NOT DETECT ANY ENDOSCOPIC ORISE GEL BULGES AND HISTOLOGIC FOREIGN BODY GRANULOMAS. ADVERSE EVENTS REPORTED WERE PROLONGED HOSPITAL STAYS FOR POST-POLYPECTOMY SYNDROME.

Additional Manufacturer Narrative

BLOCK B3: APPROXIMATED BASED ON WHEN THE ARTICLE OF INTEREST WAS PUBLISHED. BLOCK H6: IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION. BLOCK G2: STAVROPOULOS, S., OMRANI, L., GALLUB, K., GILLIAM, T., BUKANNAN, A., MODAYIL, R. (2023). ASGE COLON AND RECTUM III ENDOSCOPIC AND HISTOLOGIC FINDINGS AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WITH A NOVEL SUBMUCOSAL INJECTION SOLUTION. GASTROINTESTINAL ENDOSCOPY, 97 (6S). 10.1016/J.GIE.2023.04.889.