MAUDE Adverse Event Report: GELESIS SRL PLENITY; DELIVERY SYSTEM

Model Number MC0420

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

Patient Problems Dysphagia/ Odynophagia (1815); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Feeling the capsules stuck in her esophagus [foreign body in gastrointestinal tract] dysphagia/she was unable to tolerate swallowing.[dysphagia].Case narrative: this is a literature report received from the united states of america on (b)(6) 2023.A 39-year-adult female patient experienced dysphagia and foreign body in esophagus while on therapy with plenity for weight management.The patient's medical history included eosinophilic esophagitis (eoe) and dysphagia.The concomitant medications were not reported.On an unknown date, the patient started therapy with plenity, three capsules all at once before eating for weight management.Lot number and expiry date of plenity were not reported.On an unknown date, the patient had impaction of 3 cellulose/citric acid hydrogel capsules taken all at once before eating.She reported feeling the capsules stuck in her esophagus (pt: foreign body in gastrointestinal tract) and she was unable to tolerate swallowing (pt: dysphagia).She has had issues with dysphagia in the past, but those episodes typically improved with drinking water.At the time of presentation, she was not taking any medications for eoe.On an unknown date, esophagogastroduodenoscopy (egd) was performed and demonstrated gelatinized capsules within the esophagus at 20 cm and extending 5 cm distally.The impaction was broken down with graspers and retrieval devices, and the remaining material was pushed into the stomach.Due to the gelatinous content, it was extremely challenging to capture the loose material to be removed.Biopsies were taken of the esophagus which demonstrated mild to moderate eosinophilic infiltration.At the time of this report, treatment with plenity was unknown and the outcome of the events was unknown.This case is assessed as serious given the need for intervention required for the events dysphagia and foreign body in gastrointestinal tract.Company comment: this literature report published on (b)(6) 2022 in the american journal of gastroenterology was identified through routine monitoring of literature.It refers to a 39-year-adult female patient who experienced dysphagia and foreign body in gastrointestinal tract while on therapy with plenity for weight management.Medical history included eosinophilic esophagitis (eoe) and dysphagia.The patient experienced impaction of 3 cellulose/citric acid hydrogel capsules which were taken all at once before eating and she felt that the capsules had got stuck in her esophagus and was unable to tolerate swallowing.Esophagogastroduodenoscopy (egd) was performed which demonstrated gelatinized capsules within the esophagus at 20 cm and extending 5 cm distally.The impaction was broken down with graspers and retrieval devices, and the remaining material was pushed into the stomach.This case is assessed as serious given the need for intervention required for the events dysphagia and foreign body in gastrointestinal tract.Based on the reasonable temporal relationship, and underlying history of dysphagia that can act as a confounder, the causality is assessed as possible for the events dysphagia and foreign body in the gi tract.

• Brand Name: PLENITY
• Type of Device: DELIVERY SYSTEM
• Manufacturer (Section D): GELESIS SRL; via verdi, 188; calimera (le) 73021 ; IT 73021
• Manufacturer (Section G): GELESIS, INC.; 501 boylston street, suite 610; 2; boston MA 02116
• Manufacturer Contact: via verdi, 188; calimera (le) 73021
• MDR Report Key: 17230020
• MDR Text Key: 318177100
• Report Number: 3012121187-2023-00011
• Device Sequence Number: 1
• Product Code: QFQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN180060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MC0420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female