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); Inflammation (1932)

Event Date 10/01/2022

Event Type  Injury  

Manufacturer Narrative

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.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).

Event Description

It was reported to boston scientific corporation that orise gel was used as a lifting agent in the esophagus during an endoscopic mucosal resection (emr) procedure performed on an unknown date.A 59-year-old man underwent endoscopic surveillance 3 months after emr, in which recurrent high-grade dysplasia was found on biopsy with possible invasion into the muscularis propria.A positron emission tomography (pet) scan and computed tomography (ct) scan also noted a pet-avid area in the distal esophagus, however, could not differentiate between inflammation or recurrent carcinoma.Subsequently, the patient underwent an esophagectomy.The pathology revealed a white mass underneath the esophageal epithelium, but no surface tumor was apparent.The mass was an extensive foreign body reaction due to remnant orise gel.While barrett with high- and low-grade dysplasia was present as well, there was no evidence of residual invasive or in situ adenocarcinoma.

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 lot number; therefore, the lot expiration and device manufacture dates are unknown.Block g2: report source: literature.The citation of the journal article is below.Tsambikos, e., abreo, e., tierney, w., & hassell, l.(2020).Submucosal lifting agent-induced foreign body reaction mimicking recurrent malignancy.The american journal of gastroenterology, s1972.Https://doi.Org/10.14309/01.Ajg.0000709936.02245.Da.Block h6: impact code f19 captures the reportable event of surgical intervention due to orise gel foreign body reaction.

Event Description

It was reported to boston scientific corporation that orise gel was used as a lifting agent in the esophagus during an endoscopic mucosal resection (emr) procedure performed on an unknown date.A 58-year-old man underwent endoscopic surveillance 3 months after emr, in which recurrent high-grade dysplasia was found on biopsy with possible invasion into the muscularis propria.A positron emission tomography (pet) scan and computed tomography (ct) scan also noted a pet-avid area in the distal esophagus, however, could not differentiate between inflammation or recurrent carcinoma.Subsequently, the patient underwent an esophagectomy.The pathology revealed a white mass underneath the esophageal epithelium, but no surface tumor was apparent.The mass was an extensive foreign body reaction due to remnant orise gel.While barrett with high- and low-grade dysplasia was present as well, there was no evidence of residual invasive or in situ adenocarcinoma.Additional information received on january 27, 2023: esophagogastroduodenoscopy revealed a 1.2 cm polyp, and pathology proved intramuscular adenocarcinoma.During a subsequent endoscopic mucosal resection, orise gel was injected to lift a 2 cm semi-pedunculated polypoid mass and an extensive 4 cm 3x2 cm long adjacent area of nodular barrett's mucosa covering 80% of the circumference of the esophagus.

• 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: 15855861
• MDR Text Key: 304226608
• Report Number: 3005099803-2022-06969
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

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: 10/31/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: 92926415-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male