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

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Granuloma (1876); Obstruction/Occlusion (2422)

Event Date 07/01/2022

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.Report source: literature.The citation of the journal article is below.Dr.Badar hasan is the corresponding author.Colak y, hasan b, tandon k, khan s, wadhwa v, bejarano pa, erim t.Potential clinical complications of orisetm gel use, a new submucosal lifting agent: experience from a tertiary care center and review of the literature.Ann gastroenterol.2022 jul-aug;35(4):407-413.Doi: 10.20524/aog.2022.0726.Epub 2022 jun 2.Pmid: 35784627; pmcid: pmc9210787.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental emdr will be filed.

Event Description

It was reported to boston scientific corporation that orise gel was used as a lifting agent during a colonoscopic emr (endoscopic mucosal resection) procedure on an unknown date.The lesion was reportedly a 40 mm carpet-like sessile polyp (paris classification is) in the cecum and the initial histological diagnosis was invasive carcinoma.When visualized on follow-up colonoscopy, the orise material created a mass-like effect.The patient underwent right hemicolectomy 24 days after the procedure in which orise was injected.However, no residual adenocarcinoma or high-grade dysplasia was found on the resected surgical specimen.Furthermore, abundant (orise) material and reaction in the adipose tissue was found on the resected specimen.The patient developed postoperative complications with clinical and imaging evidence of a partial obstruction, 2 weeks after the initial surgical resection.The patient underwent another exploration with further resection at the site of anastomosis.Although negative for malignancy, this additional specimen showed orise gel eliciting the typical giant cell reaction with associated fat necrosis and inflammation by the foreign material (granulomatous reaction to orise gel).The resected specimen demonstrated serosal fibrosis and a focal foreign body reaction with residual orise gel.It was thought that the orise gel may not have been entirely removed during the first partial colectomy and potentially contributed to the small bowel obstruction in the postoperative period.

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 e1, g2: report source: literature.The citation of the journal article is below.Dr.Badar hasan is the corresponding author.Colak y, hasan b, tandon k, khan s, wadhwa v, bejarano pa, erim t.Potential clinical complications of orisetm gel use, a new submucosal lifting agent: experience from a tertiary care center and review of the literature.Ann gastroenterol.2022 jul-aug;35(4):407-413.Doi: 10.20524/aog.2022.0726.Epub 2022 jun 2.Pmid: 35784627; pmcid: pmc9210787.Block h2: block b5 was updated with additional information received on september 7, 2022 block h6: patient code e2328 captures the reported event of bowel obstruction.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 during a colonoscopic emr (endoscopic mucosal resection) procedure on an unknown date.The lesion was reportedly a 40 mm carpet-like sessile polyp (paris classification is) in the cecum and the initial histological diagnosis was invasive carcinoma.When visualized on follow-up colonoscopy, the orise material created a mass-like effect.The patient underwent right hemicolectomy 24 days after the procedure in which orise was injected.However, no residual adenocarcinoma or high-grade dysplasia was found on the resected surgical specimen.Furthermore, abundant (orise) material and reaction in the adipose tissue was found on the resected specimen.The patient developed postoperative complications with clinical and imaging evidence of a partial obstruction, 2 weeks after the initial surgical resection.The patient underwent another exploration with further resection at the site of anastomosis.Although negative for malignancy, this additional specimen showed orise gel eliciting the typical giant cell reaction with associated fat necrosis and inflammation by the foreign material (granulomatous reaction to orise gel).The resected specimen demonstrated serosal fibrosis and a focal foreign body reaction with residual orise gel.It was thought that the orise gel may not have been entirely removed during the first partial colectomy and potentially contributed to the small bowel obstruction in the postoperative period.Additional information received on september 7, 2022.The post-operative bowel obstruction requiring re-do surgery two weeks after the initial right hemicolectomy is not believed to be from the orise gel, even though some orise was found in the surgical specimen.The decision to take the patient to the operating room and perform a surgical resection was the combination of the initial pathology on the patient (invasive carcinoma) coupled with the morphologic findings on surveillance endoscopy (submucosal mass effect).

Event Description

It was reported to boston scientific corporation that orise gel was used as a lifting agent during a colonoscopic emr (endoscopic mucosal resection) procedure on an unknown date.The lesion was reportedly a 40 mm carpet-like sessile polyp (paris classification is) in the cecum and the initial histological diagnosis was invasive carcinoma.When visualized on follow-up colonoscopy, the orise material created a mass-like effect.The patient underwent right hemicolectomy 24 days after the procedure in which orise was injected.However, no residual adenocarcinoma or high-grade dysplasia was found on the resected surgical specimen.Furthermore, abundant (orise) material and reaction in the adipose tissue was found on the resected specimen.The patient developed postoperative complications with clinical and imaging evidence of a partial obstruction, 2 weeks after the initial surgical resection.The patient underwent another exploration with further resection at the site of anastomosis.Although negative for malignancy, this additional specimen showed orise gel eliciting the typical giant cell reaction with associated fat necrosis and inflammation by the foreign material (granulomatous reaction to orise gel).The resected specimen demonstrated serosal fibrosis and a focal foreign body reaction with residual orise gel.It was thought that the orise gel may not have been entirely removed during the first partial colectomy and potentially contributed to the small bowel obstruction in the postoperative period.

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.Report source: literature.The citation of the journal article is below.Dr.Badar hasan is the corresponding author.Colak y, hasan b, tandon k, khan s, wadhwa v, bejarano pa, erim t.Potential clinical complications of orisetm gel use, a new submucosal lifting agent: experience from a tertiary care center and review of the literature.Ann gastroenterol.2022 jul-aug;35(4):407-413.Doi: 10.20524/aog.2022.0726.Epub 2022 jun 2.Pmid: 35784627; pmcid: pmc9210787.Patient code e2328 captures the reported event of bowel obstruction impact code f19 captures the reportable event of surgical intervention.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental emdr will be filed.Correction: device code h6 has been corrected based on the review that the orise gel functioned as intended at the time of emr.

• 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; business & technonlogy park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15245759
• MDR Text Key: 298113795
• Report Number: 3005099803-2022-04501
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/17/2022
• Supplement Dates Manufacturer Received: 08/22/2022; 09/07/2022
• Supplement Dates FDA Received: 09/14/2022; 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female