MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORISE GEL; SUBMUCOSAL INJECTION AGENT

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

Patient Problem Granuloma (1876)

Event Date 05/01/2023

Event Type  Injury  

Event Description

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 mfr report# 3005099803-2023-03233, and a 65-year-old man captured by this report) 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 65-year-old man who underwent a colonoscopy procedure which presented a 25 mm polyp in the ascending colon.An endoscopic mucosal resection (emr) procedure was performed; however, the procedure was cancelled due to patient discomfort.Two months later, another colonoscopy was performed in which orise gel was used in an attempt to lift the polyp.This was unsuccessful due to underlying scarring and the polyp was removed by way of a cold snare and cold biopsy forceps instead.Three months later, the patient underwent another follow-up colonoscopy, which noted an unresectable polyp at the prior polypectomy site.Due to the unresectable polyp, a laparoscopic hand-assisted right hemicolectomy procedure was performed, and the patient was scheduled to return in three years for a follow-up colonoscopy.Pathological and histological evaluations noted an ill-defined tan mass within the ascending colon and a mass-forming lifting agent granuloma underlying colonic mucosa.No residual adenoma or malignancy was present.

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.

• Brand Name: ORISE GEL
• Type of Device: SUBMUCOSAL INJECTION AGENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC LIMITED; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17148591
• MDR Text Key: 317450338
• Report Number: 3005099803-2023-03232
• 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: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/16/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: 92970101-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male