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 Dysphagia/ Odynophagia (1815); Inflammation (1932); Stenosis (2263)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Block b3: approximated based on the date the article was published.Block d4, h4: the device upn and lot number are unknown; therefore, the lot expiration and device manufacture dates are unknown.Block g2: literature source journal article: kim, r.& chatila, a.(2022).Endoscopic submucosal dissection of a tumor in the upper esophageal sphincter and piriform sinus.Videogie, 7 (12), 436-438.Doi: 10.1016/j.Vgie.2022.08.009.Block h6: impact codes f2202 and f2301 capture the reportable event of repeat egd and eus and repeat dilations for ongoing stenosis.

Event Description

Boston scientific became aware of an event involving orise gel through the article, endoscopic submucosal dissection of a tumor in the upper esophageal sphincter and piriform sinus, by raymond kim, et al.Per the article, the patient underwent an endoscopic ultrasound (eus) procedure in the upper esophageal sphincter and piriform sinus.Orise gel was injected and provided adequate lift of the lesion from the muscularis propria allowing for submucosal dissection to be carried out.There were no adverse events noted during the procedure.Six months after presentation, the patient began complaining of dysphagia with esophagogastroduodenoscopy (egd) showing stenosis at the resection site requiring dilation.The patient required repeat dilations for ongoing stenosis.A pet ct scan done 10 months after presentation demonstrated focal metabolic uptake in the proximal right esophagus with a repeat egd and eus that month showing no mass or lymphadenopathy and repeat biopsies negative for recurrent disease.

Event Description

Boston scientific became aware of an event involving orise gel through the article, endoscopic submucosal dissection of a tumor in the upper esophageal sphincter and piriform sinus, by raymond kim, et al.Per the article, the patient underwent an endoscopic ultrasound (eus) procedure in the upper esophageal sphincter and piriform sinus.Orise gel was injected and provided adequate lift of the lesion from the muscularis propria allowing for submucosal dissection to be carried out.There were no adverse events noted during the procedure.Six months after presentation, the patient began complaining of dysphagia with esophagogastroduodenoscopy (egd) showing stenosis at the resection site requiring dilation.The patient required repeat dilations for ongoing stenosis.A pet ct scan done 10 months after presentation demonstrated focal metabolic uptake in the proximal right esophagus with a repeat egd and eus that month showing no mass or lymphadenopathy and repeat biopsies negative for recurrent disease.

Manufacturer Narrative

Block b3: approximated based on the date the article was published.Block d4, h4: the device upn and lot number are unknown; therefore, the lot expiration and device manufacture dates are unknown.Block g2: literature source.Journal article: kim, r.& chatila, a.(2022).Endoscopic submucosal dissection of a tumor in the upper esophageal sphincter and piriform sinus.Videogie, 7 (12), 436-438.Doi: 10.1016/j.Vgie.2022.08.009 block h2 (correction): updated block 6: patient codes to include e2326: inflammation.Block h6: impact codes f2202 and f2301 capture the reportable event of repeat egd and eus and repeat dilations for ongoing stenosis.

• 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: 17932946
• MDR Text Key: 325634611
• Report Number: 3005099803-2023-05459
• 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: Recall
• Type of Report: Initial,Followup
• Report Date: 11/14/2023

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: 09/21/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 10/25/2023
• Supplement Dates FDA Received: 11/14/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male