ORISE GEL

Additional Manufacturer Narrative

BLOCK B3: APPROXIMATED BASED ON THE DATE THE ARTICLE WAS PUBLISHED. BLOCK D4, H4: THE DEVICE UPN AND LOT NUMBER ARE UNKNOWN; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE SATOI S, ET. AL. (2022). FOREIGN BODY REACTION FOLLOWING USE OF SUBMUCOSAL LIFTING AGENT FOR ENDOSCOPIC RESECTIONS. THE AMERICAN JOURNAL OF GASTROENTEROLOGY. 117 (10S): E2154-E2154. DOI: 10.14309/01.AJG.0000870280.04417.E5 BLOCK H6: IMPACT CODES F1001 CAPTURE THE REPORTABLE EVENT OF ABORTED PROCEDURE.

Description of Event or Problem

BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING ORISE GEL THROUGH THE ARTICLE, FOREIGN BODY REACTION FOLLOWING USE OF SUBMUCOSAL LIFTING AGENT FOR ENDOSCOPIC RESECTIONS, BY SERA SATOI, ET AL. PER THE ARTICLE, THE PATIENT UNDERWENT ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE IN THE DUODENUM. TISSUE WAS LIFTED BY SUBMUCOSAL INJECTION OF 4 ML ORISE GEL; HOWEVER, THE PROCEDURE WAS ABORTED BECAUSE THE CENTER OF THE POLYP WAS FIXED AND COULD NOT BE LIFTED. 65 DAYS LATER, THE PATIENT UNDERWENT REPEAT ESOPHAGOGASTRODUODENOSCOPY (EDG) TO REMOVE THE LESION. ORISE GEL WAS ATTEMPTED; HOWEVER, THE LESION COULD NOT BE LIFTED DUE TO SEVERE FIBROSIS THUS HYBRID EMR WAS USED TO EXCISE THE LESION. PATHOLOGIC EXAMINATION REVEALED FRAGMENTS OF ADENOMA. IN ADDITION, SUBMUCOSA SHOWED FOREIGN MATERIAL WITH ASSOCIATED FOREIGN GIANT CELL REACTION, CONSISTENT WITH THE SITE PRIOR TO THE PROCEDURE.