MAUDE Adverse Event Report: GELESIS SRL PLENITY; DELIVERY SYSTEM

Model Number MC0684

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

Patient Problems Chest Pain (1776); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Esophageal perforation [oesophageal perforation].Difficulty swallowing [dysphagia].Shortness of breath [dyspnoea].Chest pain [chest pain].Feeling bloated [abdominal distension].Constipation [constipation].This initial spontaneous report was received from the united states of america reported by a ro physician on (b)(6) 2022.A 54-year-old female patient (weight: 132 lbs, bmi: 25.78) reported esophageal perforation, swallowing difficult, shortness of breath, chest pain, bloating and constipation while on plenity for weight management.The patient¿s historical condition included: nicotine use; concurrent conditions, any medical device usage, and drug allergies were not reported.The patient denied any history of narrowing, blockage, outpouching, or other problem with the esophagus; crohn's disease, ulcerative colitis, or inflammatory bowel disease; surgeries of the digestive tract; gastroesophageal reflux (gerd) or heartburn or acid reflux; stomach or intestinal ulcers; sensation of something in throat and other active gastrointestinal conditions (e.G., ibs, diverticulosis, diverticulitis, hiatal hernia) the patient¿s concomitant medications included: iron aspartate (ferrous aspartate), glycinate (magnesium glycinate), ascorbic calcium (calcium ascorbate), vitamin b12 (cyanocobalamin), calcium threonate (calcium l-threonate) and succinic acid.On (b)(6) 2022, the patient was prescribed plenity at usual dosing, route and frequency for weight management.Lot number and expiry date of plenity were not reported.On (b)(6) 2022, the patient reported taking plenity four or more days in the previous week and had side effects such as feeling bloated (pt: abdominal distension) and constipation (pt: constipation) which was counselled by a registered nurse.On (b)(6) 2022, she reported that she really enjoyed making plenity a part of her daily routine, with few or no issues and took plenity for 4 days in the preceding week.On (b)(6) 2022, the patient informed that she had an esophageal perforation (pt: oesophageal perforation) that required surgical intervention for her lower esophagus.The last thing she swallowed prior to the perforation was three plenity pills prior to her lunch and experienced difficulty swallowing (pt: dysphagia), shortness of breath (pt: dyspnoea) and chest pain (pt: chest pain).She visited to her local emergency room and then transferred to another hospital where surgery was performed and she was recovering in the hospital for ten days.She was discharged but still on a liquid diet and was advised to discontinue the plenity by her surgeon.Action taken: plenity was discontinued due to the events.Outcome of the events oesophageal perforation, chest pain, dyspnea, and dysphagia were resolving.Outcome of the events constipation and bloating was unknown.The case is assessed as serious based on the life threatening nature of the event and hospitalization requiring surgical intervention.This case was verified by a health care professional.Company comment: this spontaneous report refers to a 54-year-old female patient who reported esophageal perforation, dysphagia, chest pain, dyspnea, bloating and constipation, while on plenity for weight management.Few weeks into therapy she reported difficulty swallowing, shortness of breath and chest pain for which she was taken to er and referred to a higher hospital where she underwent surgical intervention and is currently recovering.Plenity was discontinued and the events esophageal perforation, dysphagia, chest pain, dyspnea were resolving.In the initial few days after starting plenity she experienced bloating and constipation and she reported taking plenity 4 or more days in a week.The patient¿s historical condition included nicotine use and concomitant medications included: iron aspartate, glycinate, ascorbic calcium, vitamin b12, calcium threonate and succinic acid.The case is assessed as serious based on the life threatening nature of the event and hospitalisation requiring surgical intervention.Considering the plausible temporal association (events occurred a few weeks after starting plenity) and spontaneous nature of the report, the causality for the events esophageal perforation, dysphagia, bloating, chest pain, dyspnea and constipation is assessed as possible with plenity.

Event Description

Esophageal perforation/a tear in the lower esophagus [oesophageal perforation].Difficulty swallowing [dysphagia].Shortness of breath [dyspnoea].Chest pain [chest pain].Feeling bloated [abdominal distension].Constipation [constipation].Case narrative: this initial spontaneous report was received from the united states of america reported by a ro physician on 30-jun-2022.A 54-year-old female patient (weight: 132 lbs, bmi: 25.78) reported esophageal perforation, swallowing difficult, shortness of breath, chest pain, bloating and constipation while on plenity for weight management.The patient¿s historical condition included: nicotine use; concurrent conditions were not reported and no other medical device usage reported.The patient denied any history of narrowing, blockage, outpouching, or other problem with the esophagus; crohn's disease, ulcerative colitis, or inflammatory bowel disease; surgeries of the digestive tract; gastroesophageal reflux (gerd) or heartburn or acid reflux; stomach or intestinal ulcers; sensation of something in throat and other active gastrointestinal conditions (e.G., ibs, diverticulosis, diverticulitis, hiatal hernia).The patient¿s concomitant medications included: iron aspartate (ferrous aspertate), glycinate (magnesium glycinate), ascorbic calcium (calcium ascorbate), vitamin b12 (cyanocobalamin), calcium threonante (calcium l-threonate) and succinic acid to which she had no known allergies.On (b)(6) 2022, the patient was prescribed plenity at usual dosing, route and frequency for weight management (lot number: a21299b1, expiry date: 26-apr-2023, model number: mc0684/ mc0668.1).On (b)(6) 2022, the patient reported taking plenity four or more days in the previous week and had side effects such as feeling bloated (pt: abdominal distension) and constipation (pt: constipation) which was counselled by a registered nurse.No treatment was given for these events.On (b)(6) 2022, she reported that she really enjoyed making plenity a part of her daily routine, with few or no issues and took plenity for 4 days in the preceding week.The patient informed that she had an esophageal perforation (pt: oesophageal perforation) that required thoracotomy to access the esophagus to repair a tear.The last thing she swallowed prior to the perforation was three plenity pills prior to her lunch and experienced difficulty swallowing (pt: dysphagia), shortness of breath (pt: dyspnoea) and chest pain (pt: chest pain).She visited to her local emergency room (er) where the computed tomography (ct) scan showed a tear in the lower esophagus.She was transferred via ambulance to other hospital as local er did not have the medical staff available to handle the case.On (b)(6) 2022 she was admitted in the other hospital er and underwent testing including x-rays, swallowing test, and a scope to visualize the esophagus.During thoracotomy surgery, the remnants of the plastic coating and contents of the plenity capsules were removed.The surgery took about 4 hours and following the surgery, she was shifted in the intensive care unit (icu) for several days and then transferred to an intermediate icu for some more days before she was discharged on (b)(6) 2022.She was on a liquid diet for 4 weeks and discontinued the plenity on her surgeon's advice.It had taken her 6 weeks before she was able to return to work.It had been 9 weeks and she still had plenity adverse event follow-up experience pain daily due to the surgery.She could not sleep in a sitting up position due to pain caused when lying flat on her back or on either side.Action taken: patient discontinued plenity due to the events.Outcome of the events oesophageal perforation, chest pain, dyspnea, dysphagia, abdominal distension, and constipation were resolving.The case is assessed as serious based on the life threatening nature of the event and hospitalization requiring surgical intervention.This case was verified by a health care professional.Follow-up information received on 24-aug-2022 included: patient's hospitalization dates; allergy, medical device usage, concomitant drugs, treatment related and diagnostic tests information; lot number, expiry date and model number of plenity details were updated and narrative amended accordingly.Company comment: this spontaneous report refers to a 54-year-old female patient who reported esophageal perforation, dysphagia, chest pain, dyspnea, bloating and constipation, while on plenity for weight management.The patient¿s historical condition included: nicotine use, and concomitant medications included: iron aspartate, glycinate, ascorbic calcium, vitamin b12, calcium threonante and succinic acid.Five weeks into therapy, she reported difficulty swallowing, shortness of breath and chest pain for which she was taken to er where the ct scan showed a tear in the lower esophagus.She was referred to a higher hospital where she underwent thoracotomy to access the esophagus to repair a tear.During thoracotomy, the remnants of the plastic coating and contents of the plenity capsules were also removed.Plenity was discontinued and the events esophageal perforation, dysphagia, chest pain, and dyspnea were resolving.Initially, after fifteen days of starting plenity she experienced bloating and constipation and she reported taking plenity 4 or more days in a week.The case is assessed as serious based on the life-threatening nature of the event and hospitalisation requiring surgical intervention.Considering the plausible temporal association (events occurred a few weeks after starting plenity) and spontaneous nature of the report, the causality for the events esophageal perforation, dysphagia, bloating, chest pain, dyspnea and constipation is assessed as possible with plenity.Follow-up information doesn¿t change the medical assessment of the case.

• 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: 15110745
• MDR Text Key: 296661390
• Report Number: 3012121187-2022-00612
• 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,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/26/2023
• Device Model Number: MC0684
• Device Lot Number: A21299B1
• 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: Initial
• Patient Sequence Number: 1
• Treatment: ASCORBIC CALCIUM (CALCIUM ASCORBATE),; ASCORBIC CALCIUM (CALCIUM ASCORBATE),; CALCIUM THREONATE (CALCIUM L-THREONATE),; CALCIUM THREONATE (CALCIUM L-THREONATE),; GLYCINATE (MAGNESIUM GLYCINATE),; GLYCINATE (MAGNESIUM GLYCINATE),; IRON ASPARTATE (FERROUS ASPARTATE),; IRON ASPARTATE (FERROUS ASPARTATE),; SUCCINIC ACID (SUCCINIC ACID),; SUCCINIC ACID (SUCCINIC ACID),; VITAMIN B12 (CYANOCOBALAMIN),; VITAMIN B12 (CYANOCOBALAMIN),
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Female
• Patient Weight: 60 KG