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 Pericardial Effusion (3271)

Event Type  Injury  

Event Description

Fluid around heart [pericardial effusion] couldn't walk [gait disturbance] case narrative: this initial spontaneous report was received from the united states of america reported by other care giver (girlfriend) for a consumer on 28-oct-2022, 31-oct-2022 and 02-nov-2022.A 72-year-old male patient (275 lbs) reported pericardial effusion and walking difficulty while on plenity for weight management.The patient¿s baseline weight was 352 lbs; historical conditions: knee surgery, high blood pressure, gout, and high cholesterol ; current conditions included diabetes, and fluid buildup which happened after knee surgery.He was not allergic to food but was allergic to some medications (details unspecified) ; allergic to eds and other medical devices usage was not reported.The patient concomitant medications included: humalog (insulin lispro), januvia (sitagliptin phosphate), lantus (insulin glargine), vitamins and supplements and lots of other medications (details unspecified).In (b)(6) 2022 (after (b)(6) 2022), the patient started oral therapy with plenity (lot number: a21300b1, expiration date: 27-apr-2023, and serial/udi number: (b)(4) obtained from health care professional at a dose of three capsules 30-40 minutes before lunch and dinner with 16 oz of water for weight management.On an unknown date, the patient reported fluid buildup around his heart (pt: pericardial effusion) which led to hospitalization on (b)(6) 2022.After hospitalization the patient was unable to walk (pt: gait disturbance) and was under rehabilitation.It was reported that a lot of fluid was removed from around the patient's heart.On (b)(6) 2022, the patient stopped taking plenity.It was unsure if the events were related to plenity.On (b)(6) 2022, the patient was discharged from hospital and his heart medications were changed.The patient did notify the health care professional.Action taken: patient discontinued plenity as a result of the events pericardial effusion and gait disturbance.The outcome of the events pericardial effusion was reported as resolving and for gait disturbance as not resolved.It was reported that other factors might be associated with the events.This case was not verified by a healthcare professional.Further follow-up not expected for the report.Company comment: this spontaneous report refers to a 72-year-old male patient who reported pericardial effusion and gait disturbance while on plenity for weight management.Current condition included diabetes and allergy to unspecified medications and eds; historical condition included knee surgery, high blood pressure, gout, high cholesterol and fluid buildup (occurred after knee surgery).Concomitant medications included: humalog, januvia, lantus, and lots of other medications (unspecified).This case is assessed as serious given the need for hospitalization for the event pericardial effusion.Patient discontinued plenity because of the events pericardial effusion and gait disturbance.The causality for the event pericardial effusion is assessed as unlikely related considering prior heart issues (fluid buildup) and the common etiologies of pericardial effusion being cardiac related (pericarditis, heart attack etc.), malignancy, renal failure, autoimmune disorders, and infections.Causality for the event gait disturbance is assessed as unlikely in view of elderly age group, prior history of knee surgery and underlying diabetes that can act as confounders.Additional information regarding underlying etiology, and investigations is required for a more meaningful assessment of the case.Follow up information does not 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: 15863952
• MDR Text Key: 304287175
• Report Number: 3012121187-2022-01102
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2022

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 Expiration Date: 04/27/2023
• Device Model Number: MC0420
• Device Lot Number: A21300B1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/25/2022
• 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: HUMALOG (INSULIN LISPRO).; JANUVIA (SITAGLIPTIN PHOSPHATE).; LANTUS (INSULIN GLARGINE).
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 125 KG