ORISE GEL

Additional Manufacturer Narrative

THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED IN THE DUODENUM ON AN UNKNOWN DATE. THE PATIENT WAS REFERRED FOR SURGICAL RESECTION OF A DUODENAL POLYP, WHICH HAD ORISE GEL INJECTED DURING A PREVIOUS PROCEDURE. DURING SURGICAL RESECTION, THE PHYSICIAN NOTICED WHITE SEROSAL PLAQUES ON THE DUODENUM AWAY FROM THE PRIMARY POLYP. ADDITIONAL BIOPSIES WERE PERFORMED ON THE WHITE SEROSAL PLAQUES AND WERE IDENTIFIED AS A FOCAL COLLECTION OF ORISE GEL. IN THE PHYSICIAN'S ASSESSMENT, IT IS DOUBTFUL THESE ARE DIRECT INJECTIONS AS THEY ARE FAR FROM THE PRIMARY LESION. IT WAS DETERMINED THAT THE MIGRATION OF ORISE GEL RESULTED IN A FOREIGN BODY RESPONSE (INFLAMMATION), WHICH CAUSED THE PATIENT TO UNDERGO ADDITIONAL BIOPSY/INTERVENTION THAT WAS NOT PART OF THE ORIGINAL SURGERY.