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

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

Patient Problems Granuloma (1876); Fibrosis (3167)

Event Date 03/01/2023

Event Type  Injury  

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 h6: imdrf impact code f19 captures the reportable event of surgical intervention.

Event Description

It was reported to boston scientific corporation that orise gel was used as a lifting agent in the rectum (8cm from anal verge) during a piecemeal endoscopic mucosal resection (emr) procedure performed on an unknown date.Biopsy results from the initial piecemeal emr procedure demonstrated a focus of poorly differentiated carcinoma arising from the tva with less than 1 mm clear margins posteriorly.A computed tomography (ct) scan showed no evidence of metastases and a pelvic magnetic resonance imaging (mri), completed 6 weeks post emr to minimize artifact, demonstrated a mrt3n0 rectal mass with questionably threatened mesorectal fascia.A carcinoembryonic antigen (cea) test was performed, which showed a level of 1 ng/ml.A repeat sigmoidoscopy procedure was performed and there was no evidence of residual disease, but thickening of the biopsy site was noted.Endorectal ultrasound confirmed a ut3n0 rectal mass.Upon review at the multidisciplinary tumor board, neoadjuvant treatment followed by a total mesorectal excision (tme) was recommended.The patient was reluctant to undergo chemoradiation and sought a second opinion at another institution where additional biopsies were taken of the prior emr site and demonstrated fibrosis.Based on the discrepancy between endoluminal, histologic and radiographic staging, the patient opted for upfront surgery, which was performed 3.5 months following the initial emr.The patient underwent laparoscopic low anterior resection without diverting loop ileostomy and was discharged home without complication.The final pathology showed no evidence of lymphovascular invasion.The prior emr site featured an ill-defined expansile mass-like lesion with associated acellular mucin-like material and extensive foreign giant cell reaction, involving submucosa, muscularis propria, and subserosa, consistent with lifting agent granuloma.

• 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 CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16711058
• MDR Text Key: 313005094
• Report Number: 3005099803-2023-01723
• 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: 04/11/2023

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: 03/16/2023
• Initial Date FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 92970101-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention