ORISE GEL

Description of Event or Problem

BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF MULTIPLE EVENTS THROUGH THE ARTICLE "LIFTING AGENT GRANULOMA PRESENTING AS A COLONIC MASS MIMICKING CANCER: A REPORT OF THREE CASES" WRITTEN BY NICOLE L. MENDELSON, ET AL. ACCORDING TO THE LITERATURE, THREE CASES (A 58-YEAR-OLD WOMAN CAPTURED BY THIS REPORT, A 61-YEAL-OLD MAN CAPTURED BY MFR REPORT# 3005099803-2023-03233, AND A 65-YEAR-OLD MAN CAPTURED BY MFR REPORT # 3005099803-2023-03232) WERE IDENTIFIED BASED ON THE HISTOLOGICAL PRESENCE OF A LIFTING AGENT GRANULOMA IN A COLONIC/COLORECTAL RESECTION SPECIMEN WITH ASSOCIATED CLINICAL, IMAGING AND GROSS CONCERN FOR INVASIVE MALIGNANCY. ALL THREE CASES RESULTED IN CLINICAL AND SURGICAL INTERVENTION DUE TO THE SUSPICION OF AN UNRESECTABLE LESION THAT WAS AT LEAST PARTIALLY INVOLVED BY A GRANULOMATOUS REACTION DUE TO THE USE OF ORISE GEL LIFTING AGENT. THIS REPORT CAPTURES THE EVENT OF A 58-YEAR-OLD WOMAN WITH A HISTORY OF ADENOMAS WHO UNDERWENT A COLONOSCOPY PROCEDURE, WHICH REVEALED A 30 MM SESSILE MULTILOBED POLYP IN THE SIGMOID COLON. REPORTEDLY, THE POLYP WAS LIFTED EASILY USING ORISE GEL LIFTING AGENT AND REMOVED PIECE BY PIECE. PATHOLOGY NOTED A WELL-DIFFERENTIATED ADENOCARCINOMA. TEN DAYS LATER, A FLEXIBLE SIGMOIDOSCOPY SHOWED ULCERATION AT THE POLYPECTOMY SITE. ONE MONTH LATER, THE PATIENT UNDERWENT A LAPAROSCOPIC HAND-ASSISTED LOW ANTERIOR RESECTION FOR SIGMOID COLON CANCER. A SUBMUCOSAL MASS WAS FOUND UPON OPENING THE SPECIMEN, LEADING TO AN ADDITIONAL DISTAL RESECTION. THE RESIDUAL SESSILE POLYP WAS FOUND NEAR THE ORIGINAL POLYPECTOMY SITE. THE PATIENT RETURNED FOR A ONE-YEAR FOLLOW-UP COLONOSCOPY PROCEDURE WHICH SHOWED NO EVIDENCE OF MALIGNANCY. PATHOLOGICAL AND HISTOLOGICAL EVALUATION NOTED A WELL-DEFINED RAISED SUBMUCOSAL SOLID YELLOW-TAN LESION, RESIDUAL ADENOCARCINOMA, AND AN UNDERLYING LIFTING AGENT GRANULOMA.

Additional Manufacturer Narrative

BLOCK B3: 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. BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G2: REPORT SOURCE: LITERATURE. DR. AMER K. ABU ALFA IS THE CORRESPONDING AUTHOR. JOURNAL ARTICLE: MENDELSON NL, ELLIOTT KR, EVANS KE, FRISCH NK, ABU ALFA AK. LIFTING AGENT GRANULOMA PRESENTING AS A COLONIC MASS MIMICKING CANCER: A REPORT OF THREE CASES. AME CASE REP 2023;7:6. DOI: 10.21037/ACR-22-59.