MAUDE Adverse Event Report: GELESIS SRL PLENITY; DELIVERY SYSTEM

Model Number MC0420

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

Patient Problem Foreign Body In Patient (2687)

Event Date 03/29/2022

Event Type  Injury  

Event Description

3 capsules were stuck in her esophagus [foreign body in gastrointestinal tract].Case narrative: this initial spontaneous report was received from the united states of america reported by a ro physician on (b)(6) 2022.A (b)(6) patient (weight-(b)(6)) of unknown gender reported foreign body in esophagus while on plenity for obesity.The patient's medical procedures included: knee surgery and shoulder surgery.The patient¿s current medical condition included fatty liver disease started on (b)(6) 2020; allergy history included: allergic to bees, nickel, nuts, milk.It was reported that, the patient had a long history of rice, pasta and bread getting stuck in her esophagus.The patient¿s concomitant medications and usage of other medical devices were not provided.On (b)(6) 2022, the patient started therapy with plenity (lot number: a21280b1; expiry date not reported) at a dose of three capsules, orally, twice daily 30 minutes before meal for obesity.On (b)(6) 2022, three capsules were stuck in her esophagus (pt: foreign body in gastrointestinal tract) that she could not clear.The patient attempted to self-induce vomiting without success and went to the emergency room and endoscopy (esophageal scoping) was performed to remove the blocked plenity capsules.On (b)(6) 2022, the use of plenity was discontinued.The patient was on a liquid diet for the next 4 weeks and could not take medications.On (b)(6) 2022, the patient planned to have repeat surgical intervention with the gastrointestinal surgical team to widen and stretch her esophagus.It was reported that there was a suspicion that plenity or the patient underlying medical history of food getting stuck in her throat might have contributed to the event.The case is assessed as serious based on hospitalization and surgical intervention in the form of endoscopic removal of plenity capsules for resolution of the symptoms.Action taken: patient discontinued plenity as a result of event.The outcome of the event was resolved at the time of this report.This case was verified by a healthcare professional.Company comment: this spontaneous case refers to a (b)(6) female patient who reported that plenity capsules were stuck in her esophagus (pt: foreign body in gastrointestinal tract) 7 days after starting plenity for obesity.Patient self induced vomiting to remove the capsules, however was not successful.She was then taken to er room where endoscopic removal of plenity capsules was performed.She was kept on liquid diet for next 4 weeks and surgery was scheduled after a few days to widen and stretch her esophagus.Her medical history was significant for similar symptoms in the past to rice, pasta and bread and normally she self induces vomiting to clear her throat.Other medical history includes unspecified knee and shoulder surgery, fatty liver disease and allergy to milk, nuts, bees and nickel.The case is assessed as serious based on hospitalization and surgical intervention in the form of endoscopic removal of plenity capsules for resolution of the symptoms.Based on the reasonable temporal relationship, causality is assessed as possible.However, medical history of similar symptoms and planned surgical intervention to dilate esophagus possibly indicates underlying esophageal disorder which could have contributed to the symptoms.

• 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: 14220360
• MDR Text Key: 290187749
• Report Number: 3012121187-2022-00050
• Device Sequence Number: 1
• Product Code: QFQ
• Combination Product (y/n): N
• PMA/PMN Number: DEN180060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MC0420
• Device Lot Number: A21280B1
• 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): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 82 KG