MAUDE Adverse Event Report: GELESIS, INC. PLENITY; DELIVERY SYSTEM

Model Number MC0420

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

Patient Problem Dyspnea (1816)

Event Date 02/01/2021

Event Type  Injury  

Event Description

Difficulty breathing [dyspnoea], heart palpitations [palpitations].Case narrative: this initial spontaneous report was received from the united states of america reported by a physician on (b)(6) 2021.A (b)(6) female patient ((b)(6)) experienced difficulty breathing and heart palpitations while on plenity for obesity.The patient¿s body mass index (bmi) was 34 and her medical history included obesity and depression.The patient denied eating disorder or undergoing gastrointestinal (gi) surgery or bariatric procedure.The patient was allergic to penicillin.The patient's concomitant medications included: seroquel (quetiapine fumarate), adderall (amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, and dextroamphetamine sulfate), and hydrocodone (hydrocodone bitartrate).On (b)(6) 2021, the patient was prescribed plenity and on an unspecified date, she started therapy with plenity, three capsules by mouth taken with two meals a day for obesity.The lot number and expiry date of plenity were not reported.On (b)(6) 2021, the patient had difficulty breathing (pt: dyspnoea) and heart palpitations (pt: palpitations) and was hospitalized for 3 days.It was also reported that the patient did not recall the details of the diagnostic tests conducted and treatments received during hospitalization except intravenous fluids.It was reported that, on (b)(6) 2021, the patient¿s symptoms disappeared and she recovered from the events and was discharged from the hospital on the same day.The patient was suggested to discontinue treatment with plenity, and on an unspecified date in (b)(6) 2021, the patient stopped therapy with plenity.Action taken with plenity in response to the events was reported as withdrawn.The outcome of the events (difficulty breathing and heart palpitations) was resolved at the time of this report.The case was considered serious due to hospitalization.This case was verified by a healthcare professional.Company comment: this spontaneous report by a physician refers to (b)(6) female patient ((b)(6), bmi 34) who experienced difficulty breathing and heart palpitations while on plenity for obesity.Patient¿s medical history included obesity and depression and denied any eating disorder, gastrointestinal (gi) surgery or any bariatric procedure.The patient had a history of allergy to penicillin and concomitant medications included seroquel (quetiapine fumarate), adderall (amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, and dextroamphetamine sulfate), and hydrocodone (hydrocodone bitartrate).The physician reported that the actual start date of plenity was unknown, but prescription plan was executed on (b)(6) 2021.It was assumed that the patient started taking plenity the same day of prescription.On (b)(6) 2021, 11 days after prescription of plenity, patient had trouble breathing (pt: dyspnoea) and heart palpitations (pt: palpitations) and was hospitalized the same day.Patient could not recall specifics on treatment received during hospitalization except intravenous fluids.On (b)(6) 2021, the events resolved, and patient was discharged.The physician reported that the events resolved after discontinuing plenity and patient was advised against resuming plenity.The events were assessed as serious due to the hospitalization and need for treatment with intravenous fluids.Case lacks details on diagnosis, diagnostic work up, and details of specific treatment provided in the hospital.Although symptoms of dyspnea and palpitations and treatment with intravenous fluids raise a possibility of anaphylactic reaction, the report lacks information supporting it.Additionally, given the ongoing psychiatric illness and treatment with psychotropic medications and lack of details on when the patient started taking plenity, role of underlying illness/psychotropic medications or a possibility of interaction of plenity with these medications could not be ruled out.Nonetheless, causality to plenity was assessed as possibly related given the plausible temporal relationship and the resolution of symptoms after discontinuing plenity.

• Brand Name: PLENITY
• Type of Device: DELIVERY SYSTEM
• Manufacturer (Section G): GELESIS, INC.; 501 boylston street, suite 610; 2; boston MA 02116
• Manufacturer Contact: via verdi, 188 calimera (le); puglia, it 73021
• MDR Report Key: 11424649
• MDR Text Key: 247139617
• Report Number: 3012121187-2021-00263
• 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: 03/05/2021

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: Lay User/Patient
• Device Model Number: MC0420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2021
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 82