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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/26/2022

Event Type  Injury  

Event Description

Kidney failure/renal failure [renal failure] ; patient's right kidney had blocked and swollen [hydronephrosis] ; mass of dead blood vessels behind kidney [vascular malformation] ; very sick [illness] ; food intolerance [food intolerance] ; vomiting [vomiting].Case narrative: this initial spontaneous report was received from the united states of america via ro healthcare professional (nurse practitioner) on (b)(6) 2023.A 41-year-old female patient (weight: 160 lbs) reported kidney failure, hydronephrosis, vascular anomaly, sickness, food intolerance, and vomiting while on plenity for weight management.The patient¿s body mass index (bmi) was 25.8 and her historical condition included binge eating (scored 6 on the binge eating scale), infertility issues with in-vitro fertilization in the past.The patient¿s current conditions, concomitant medications and drug allergies were not reported.On (b)(6) 2022, the patient started therapy with plenity at a dose of three capsules 20-40 minutes before two biggest meals for weight management.The lot number and expiry date of plenity were not reported.On (b)(6) 2022, the patient experienced very sick (pt: illness), which escalated to daily food intolerance (pt: food intolerance) and vomiting (pt: vomiting) through (b)(6) 2023, and the patient lost 15 kilos, but obviously not in a healthy way.On (b)(6) 2023, the patient¿s right kidney had blocked, and swollen (pt: hydronephrosis) and there was a mass of dead blood vessels behind it (pt: vascular malformation) and almost had renal failure (pt: renal failure) and was admitted to hospital for first surgery and was hospitalized for a week.The patient stopped taking plenity in feb last week.On an unknown date, the patient underwent nuclear and cti scans, and ended in emergency room.The results were unknown.On (b)(6) 2023, the patient recovered from the event and was discharged from hospital.On (b)(6) 2023, the patient had second surgery for her kidney problem.The hcp felt the event was not related to plenity and might have more than likely been an underlying condition exacerbated.Action taken: the patient discontinued plenity as a result of events.The outcome of the events (illness, food intolerance, vomiting, hydronephrosis, vascular malformation, renal failure) were resolved.The case was assessed as serious due to hospitalization and intervention required.This case was verified by a healthcare professional.Company comment: this spontaneous report refers to a 41-year-old female patient who reported renal failure, hydronephrosis, vascular malformation, illness, food intolerance, and vomiting while on plenity for weight management.Her historical condition included binge eating (scored 6 on the binge eating scale), infertility issues with in-vitro fertilization in the past.The patient reported that she started getting very sick after 1 month of starting plenity therapy which escalated to daily food intolerance and vomiting.Patient was very unwell and consulted her doctor who advised her to stop taking plenity.She got nuclear and cti scans and ended in er.Patient reported having developed kidney problems for which she underwent two surgeries.Her right kidney had blocked, and was swollen and there was a mass of dead blood vessels behind it.She was admitted to hospital for first surgery and was hospitalized for a week.20 days later the patient had second surgery for her kidney problem.This case is assessed as serious given the need for hospitalization and intervention required for the event renal failure and hospitalization for hydronephrosis and vascular malformation.Due to lack of information regarding medical history, details about the hospitalization, surgery performed, investigations done and treatment provided the causality for the event renal failure, hydronephrosis and vascular malformation is assessed as not assessable.Based on the reasonable temporal relationship, and spontaneous nature of the report, the causality is assessed as possible for the events illness, food intolerance and vomiting.More information regarding relevant medical history, concomitant medications, investigations, hospitalization and surgery details is required for a more meaningful 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: 17189743
• MDR Text Key: 317726155
• Report Number: 3012121187-2023-00010
• 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: Other
• Type of Report: Initial
• Report Date: 06/23/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2023
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 73 KG