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 05/27/2022

Event Type  Injury  

Event Description

Hiatal hernia worsened and large abdominal surgery for hernia repair [hiatus hernia].Liver mass was ablated and drained [hepatic neoplasm].Gallbladder was removed [cholecystectomy].She had her ovary removed due to a mass [ovarian mass].Patient taking plenity with 8 oz of water [wrong technique in device usage process].Case narrative: this initial spontaneous report was received from the united states of america reported by a consumer on (b)(6) 2022 and (b)(6) 2022.A 66-year-old female patient (weight: 216 lbs) reported hiatal hernia, liver tumor nos, cholecystectomy, ovarian mass and wrong technique in device usage process while on plenity for weight management.The patient's baseline weight was 233 lbs and current weight was 213 lbs; current medical conditions included: high blood pressure, over active bladder, depression, and history of hiatal hernia for five years.Patient did not have any allergies.Concomitant medications includes multivitamin, metoprolol for high blood pressure, prstiq (desvenlafaxine succinate monohydrate) for depression; and myrbetriq (mirabegron) for overactive bladder.On (b)(6) 2022, the patient started plenity therapy at three capsules with 8 oz of water, 30 mins before to lunch and dinner for weight management (pt: wrong technique in device usage process).The lot number and expiry date of plenity were not reported (box was discarded).It was reported that, her hiatal hernia was worsened over the years.In (b)(6) 2022 to assess the hiatal hernia, an ultrasound was performed which revealed that hiatal hernia had caused 80% of stomach to be in esophagus.On (b)(6) 2022, the patient had large abdominal surgery for hernia repair (pt: hiatus hernia), during the surgery her liver mass was ablated and drained (pt: hepatic neoplasm) and gallbladder was removed (pt: cholecystectomy).Patient reported that, it was unclear how the liver mass and gallbladder issues were diagnosed.Because of surgery, patient was hospitalized for six days, at discharge time breathing device given to use.It was reported that, plenity was not the cause of her surgery, and she didn't have any symptoms prior to plenity.Patient treating physicians felt that events were not related to use of plenity.In 2022 (exact date was unknown), the patient stopped taking plenity and did not use for full four weeks.After surgery, she was better, still recovering from the surgery.It was reported that, possibly one month after hospitalization, her ovary was removed due to a mass (pt: ovarian mass).At the time of this report, plenity was not restarted.Action taken: patient temporarily discontinued plenity due to events (hiatus hernia, hepatic neoplasm, cholecystectomy).Outcome of the events (hiatus hernia, hepatic neoplasm, cholecystectomy) was reported as resolving at the time of this report.Outcome of the event ovarian mass is unknown.This case is assessed as serious based on the seriousness criteria of intervention done and hospitalization this case was not verified by a healthcare professional.Company comment: this spontaneous report refers to a 66-year-old female patient who reported hiatal hernia, hepatic neoplasm, cholecystectomy, ovarian mass, and wrong technique in device usage process after starting plenity for weight management.Current medical conditions include high blood pressure, overactive bladder, hiatal hernia, and depression; and concomitant medications includes multivitamin, metoprolol, prstiq and myrbetriq.Patient had a 5-year history of hiatal hernia which had worsened over the years and had to undergo hernia repair surgery after 7weeks of starting plenity and during this surgery liver mass ablation and cholecystectomy were performed.The patient was hospitalized for 6 days and was recovering; and plenity was discontinued.A month after the hospitalization she had her ovary removed due to a mass.The patient was drinking 8 oz of water with plenity.This case is assessed as serious based on the seriousness criteria of intervention done and hospitalization.The causality for the event hiatal hernia is assessed as not related considering underlying chronic history of hiatal hernia.Causality for the events hepatic neoplasm, cholecystectomy, and ovarian mass is assessed as not assessable due to lack of adequate information on the event details like its precise etiology, signs and symptoms and indication for the procedure.The causality for the event wrong technique in device usage process is assessed as not applicable as it is regarded as a special situation.

• 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: 15025878
• MDR Text Key: 295953138
• Report Number: 3012121187-2022-00514
• 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: 07/15/2022

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 Model Number: MC0420
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2022
• 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: A
• Patient Sequence Number: 1
• Treatment: METOPROLOL (METOPROLOL),; MYRBETRIQ (MIRABEGRON).; PRISTIQ (DESVENLAFAXINE SUCCINATE MONOHYDRATE),
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 98 KG