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 COMPLAINANT INDICATED THAT 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 ASCENDING COLON DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED IN EARLY (B)(6) 2022. THE PATIENT RECEIVED AN INITIAL ENDOSCOPIC PROCEDURE USING ORISE GEL TO ATTEMPT TO LIFT THE POLYP IN THE ASCENDING COLON IN (B)(6) 2021, HOWEVER WAS REFERRED FOR A SECOND PROCEDURE FOR A MORE ADVANCED ENDOSCOPIC TECHNIQUE. DURING THE ESD PROCEDURE, SIGNS OF NON-LIFTING WAS OBSERVED WHEN ORISE GEL WAS INJECTED INTO THE CENTER OF THE POLYP. ACCORDING TO THE PHYSICIAN, THIS IS TYPICALLY A SIGN OF INVASIVE CANCER. THE TISSUE WAS HARD/DENSE IN THE SUBMUCOSAL LAYER AS THE PHYSICIAN TRIED TO CUT THROUGH IT WITH AN ORISE PROKNIFE. IT WAS NOT POSSIBLE TO DISSECT BELOW THE DENSE TISSUE, SO THEY CUT THROUGH IT TO COMPLETE THE ENDOSCOPIC RESECTION. THE ESD PROCEDURE WAS COMPLETED SUCCESSFULLY. DUE TO THE CONCERN FOR CANCER, THE PATIENT UNDERWENT A RIGHT HEMICOLECTOMY ON (B)(6) 2022. AFTER COMPLETING THE SURGERY, THE AREA WITH THE POLYP WAS NOTED TO BE HARD WHEN PALPITATED BY HAND. THE PATHOLOGIST REPORTED THAT THE SURGICAL SPECIMEN HAD A GIANT CELL REACTION/GRANULOMA IN THE AREA OF CONCERN. IN THE PHYSICIAN'S ASSESSMENT, THE GRANULATOMOUS RESPONSE MIGHT HAVE BEEN ATTRIBUTED TO ORISE GEL BEING INJECTED INTO THE MUSCULARIS LAYER AND/OR DUE TO ORISE GEL BEING ENCAPSULATED WITHOUT ANY RESECTION ATTEMPT DURING THE INITIAL ENDOSCOPIC PROCEDURE IN (B)(6) 2021. THE RESULTS FROM PATHOLOGY DID NOT SHOW CANCER, ONLY GRANULOMA.