ORISE GEL

Additional Manufacturer Narrative

THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL EMDR WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED IN THE RECTUM DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE ON (B)(6) 2020. DURING THE PROCEDURE, TWO POLYPS WERE IDENTIFIED APPROXIMATELY 5CM FROM THE ANAL VERGE. ABOUT 5CC OF ORISE GEL WAS USED TO LIFT BOTH POLYPS PRIOR TO REMOVAL. STANDARD TECHNIQUE OF ORISE INJECTION WAS PERFORMED BY INJECTING THE GEL WHILE SLOWLY WITHDRAWING THE NEEDLE FROM THE TARGET SITE. PROCEDURE FINDINGS: POLYP 1: 4MM - PATHOLOGY SHOWED TUBULAR ADENOMA WITH HIGH GRADE DYSPLASIA. MARGINS INVOLVED. POLYP 2: 15MM - PATHOLOGY SHOWED TUBULAR ADENOMA WITH HIGH GRADE DYSPLASIA. NO MARGINS INVOLVED. ON (B)(6) 2020 A FOLLOW-UP PROCEDURE WAS PERFORMED FOR THE POLYP WITH THE POSITIVE MARGIN, WHICH FOUND AN ELEVATED DISTORTION THAT WOULD NOT LIFT WITH ORISE. A FEW DAYS LATER, A RECTAL ULTRASOUND WAS PERFORMED WHICH SHOWED SUBMUCOSAL THICKENING AND A LESION NOT AMENDABLE TO ENDOSCOPIC RESECTION. AN MRI WAS PERFORMED THAT WAS READ AS POSSIBLE PERI-RECTAL LYMPH NODES. THE PATIENT WAS REFERRED TO SURGERY FOR A TRANSANAL RESECTION. PATHOLOGY SHOWED DENSE EOSINOPHILIC FOREIGN BODY REACTION WITH GIANT CELLS. NO TUBULAR ADENOMA, OR HIGH-GRADE DYSPLASIA WAS IDENTIFIED.