ORISE GEL

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.

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 MFR REPORT# 3005099803-2023-03216, A 61-YEAL-OLD MAN CAPTURED BY THIS REPORT, 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 61-YEAR-OLD MAN WHO WAS FOUND TO HAVE A HEPATIC FLEXURE POLYP WHILE UNDERGOING A COLONOSCOPY PROCEDURE. THE POLYP WAS REMOVED USING ORISE GEL AS A LIFTING AGENT DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE. PATHOLOGY NOTED INTRAMUCOSAL ADENOCARCINOMA. ROUGHLY TWO WEEKS LATER, THE PATIENT UNDERWENT ANOTHER COLONOSCOPY WHICH REVEALED ANOTHER POLYP IN THE SAME AREA AS THE INITIAL EMR; HOWEVER, THIS FLAT CARPETING POLYP COULD NOT BE REMOVED ENDOSCOPICALLY. DUE TO THE CONCERN FOR INVASIVE CARCINOMA, THE PATIENT UNDERWENT A LAPAROSCOPIC HAND-ASSISTED RIGHT HEMICOLECTOMY AND WAS SCHEDULED TO UNDERGO A FOLLOW-UP COLONOSCOPY THREE YEARS LATER. PATHOLOGICAL AND HISTOLOGICAL EXAMINATIONS REVEALED AN ILL-DEFINED MASS THAT APPEARED TO INVADE THE MUSCULARIS PROPRIA AND MASS-FORMING LIFTING AGENT GRANULOMA AT THE HEPATIC FLEXURE WITH OVERLYING RESIDUAL ADENOMA. NO MALIGNANCY WAS PRESENT.