MAUDE Adverse Event Report: ORISE GEL (ORISE GEL); SUBMUCOSAL INJECTION AGENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Granuloma (1876); Reaction to Medicinal Component of Device (4574)

Event Date 07/16/2021

Event Type  Injury  

Event Description

Per (b)(6) 2202 gi note: "(b)(6) y/o in chronic phase cml (dx 2003), previously on imatinib 600 mg daily, with continued mmr (major molecular response), and ida, prior adenomatous polyps, with recent colonoscopy (b)(6) 2021 with recurrent sigmoid 20 mm stricture at site of prior resection due to emr lifting agent, now s/p partial colectomy [pt] underwent a surveillance colonoscopy (b)(6) 2021, during which he was found to have multiple polyps, including a recurrent 20 mm lst at the site of a prior resection in the sigmoid colon (path c/w tva).Pt then underwent a repeat colonoscopy (b)(6) 2021.During this colonoscopy he was found to have a new stricture at the site of the prior resection, which was balloon dilated to 12 mm.Giant cell reaction to lifting agent resulting in stricture.Notably surgical pathology demonstrated that stricture was likely caused by giant cell reaction to emr lifting agent (likely orise which was used in (b)(6) 2021 colonoscopy).Use saline only for emr in the future.Per (b)(6) 2021 discharge summary for colectomy procedure: "(b)(6) y/o male with pmhx of cml on imatinib in remission, bipolar disease on vpa, and recurrent adenomatous polyps of the sigmoid colon s/p endoscopic resection c/b stricture who was admitted for resection of his stricture.He pre-admitted on "(b)(6)" and underwent bowl prep and was treated with pre-op neomycin and flagyl.He was brought to the operating room on "(b)(6)" and underwent a laparoscopic converted to open partial colectomy.The case was complicated by inability to identify the stricture initially, thus gi was called into the operating room and performed and intra-operative colonoscopy, and identified and inked a stricture in the descending colon.We then proceeded with a descending colectomy.He tolerated the procedure without complication and was admitted post-operatively for monitoring." colonic stricture, hospitalization, giant cell reaction granuloma, colectomy.Dosing: injected into gi mucosa.Dates of use: (b)(6) 2021.Diagnosis for use: colonoscopy.

• Brand Name: ORISE GEL (ORISE GEL)
• Type of Device: SUBMUCOSAL INJECTION AGENT
• MDR Report Key: 13783295
• MDR Text Key: 287584195
• Report Number: MW5108191
• Device Sequence Number: 1
• Product Code: PLL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male