MAUDE Adverse Event Report: GELESIS SRL PLENITY; DELIVERY SYSTEM

Model Number MC0420

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

Patient Problems Aspiration/Inhalation (1725); Foreign Body In Patient (2687); Gastrointestinal Hemorrhage (4476); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/01/2022

Event Type  Injury  

Event Description

Pill got lodged in my esophagus and expanded [device malfunction]; pill got lodged in my esophagus and expanded [foreign body in gastrointestinal tract]; esophageal bleeding post endoscopy [oesophageal haemorrhage]; aspiration post endoscopy [aspiration]; i took my pills before lunch on tues [wrong technique in device usage process].Case narrative: this initial spontaneous report was received from the united states of america via ro physician on (b)(6) 2022.A 47-year-old female patient (weight: 230 lbs) reported device malfunction, foreign body in esophagus, esophageal bleeding, aspiration of gastrointestinal contents into airways, and wrong technique in device usage process while on plenity for weight loss.The patient¿s concurrent conditions included: gerd (gastroesophageal reflux disease-controlled with over the counter medications), obstructive sleep apnea (controlled by continuous positive airway pressure therapy), fatty liver disease, asthma, depression and atopic dermatitis.The patient¿s medical procedures included: hysterectomy, breast augmentation, tummy tuck, endoscopy and continuous positive airway pressure (cpap).The patient¿s drug allergies and usage of other medical devices were not provided.The patient¿s concomitant medications included: unspecified gerd medication, albuterol, dupixent (dupilumab), bupropion (bupropion hydrochloride) and venlafaxine (venlafaxine hydrochloride).On (b)(6) 2022, the patient started therapy with plenity at a dose of 3 capsules, orally before lunch for weight loss.Lot number and expiry date of plenity were not reported.On 24-feb-2022 (tuesday), the patient took pills before lunch (pt: wrong technique in device usage process) and a pill got lodged in esophagus (pt: foreign body in gastrointestinal tract) and expanded (pt: device malfunction).The patient went to emergency room (er) and endoscopy was performed to remove the gelatin capsule.The gelatin got coagulated and had trouble dislodging it.Hence, the patient had complications of esophageal bleeding (pt: oesophageal haemorrhage) and aspiration (pt: aspiration) post procedure and was hospitalized.On 02-mar-2022, the patient was discharged with pain medications (not specified) and advised to follow-up with physician on wednesday for esophagram.Based on the patient condition, emergency room visit and endoscopy procedure.This case was assessed as serious as patient required medical intervention in the form of endoscopic removal of expanded gel in her esophagus and because of endoscopic complications (aspiration and esophageal bleeding) which resulted in hospitalization.Action taken: patient discontinued plenity due to events (device malfunction and foreign body in gastrointestinal tract).Outcome of the events oesophageal haemorrhage and aspiration was unknown.This case was verified by a healthcare professional.A medical device complaint had been registered with this report.Company comment: this case refers to a (b)(6) female patient who reported that plenity capsule lodged in her esophagus (pt: foreign body in gastrointestinal tract) and expanded there (pt: device malfunction) approximately a week after initiating therapy with plenity, 3 capsules before lunch (pt: wrong technique in device usage process) for weight loss.Patient visited er as a result of the event where she underwent endoscopic removal of the expanded gel.The procedure was complicated by esophageal haemorrhage and aspiration as a result of which patient was hospitalized.She was discharged the next day.Medical history is significant for gerd, obstructive sleep apnea controlled by continuous positive airway pressure therapy), fatty liver disease, asthma, depression and atopic dermatitis.The patient¿s medical procedures included: hysterectomy, breast augmentation and tummy tuck procedure.Concomitant medications include albuterol and dupilumab for asthma; and bupropion and venlafaxine for depression.The case is assessed as serious as patient required medical intervention in the form of endoscopic removal of expanded gel in her esophagus and because of endoscopic complications (aspiration and esophageal bleeding) which resulted in hospitalization.Based on the reasonable temporal relationship and nature of the events, causality is assessed as probable for device malfunction and foreign body in gastrointestinal tract.Esophageal haemorrhage and aspiration are considered as unlikely related to plenity and likely related to the endoscopic procedure itself, and the role of plenity in contributing to these events could not be ruled out completely.Causality for wrong technique in device usage process is not applicable.

• 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: 13789578
• MDR Text Key: 292499674
• Report Number: 3012121187-2022-00028
• 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: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MC0420
• 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: A
• Patient Sequence Number: 1
• Treatment: ALBUTEROL (ALBUTEROL); BUPROPION (BUPROPION HYDROCHLORIDE); DUPIXENT (DUPILUMAB); VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 104 KG