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 Obstruction/Occlusion (2422); Pancreatitis (4481)

Event Date 04/28/2022

Event Type  Injury  

Event Description

Blockage of the common bile duct that caused the acute pancreatitis [biliary obstruction].Acute pancreatitis [pancreatitis acute].Case narrative: this initial spontaneous report was received from the united states of america reported by a ro physician on (b)(6) 2022.A 47-year-old female patient (weight: 207 lbs) experienced bile duct obstruction, acute pancreatitis while on plenity for unknown indication.The patient¿s surgical history includes obstructive sleep apnea s/p surgery, uvula ,repair deviation septum, tonsillectomy, 2 c-section, lumbar laminectomy, and appendectomy; concomitant medication included junel fe (ethinylestradiol, ferrous fumarate and norethisterone acetate) for 28 days, venlafaxine (venlafaxine hydrochloride) and multivitamin (ascorbic acid, calcium pantothenate, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, and thiamine hydrochloride).The patient's drug allergies and other medical device usage were not reported.On (b)(6) 2022, the patient started therapy with plenity at a standard dose, for an unknown indication.Lot number and expiry date of plenity were not reported.On (b)(6) 2022, the patient had a blockage of the common bile duct (pt: biliary obstruction) that caused the acute pancreatitis (pt: pancreatitis acute).On an unknown date, the patient underwent magnetic resonance imaging (mri), magnetic resonance cholangiopancreatography (mrcp) without contrast results revealed that impression solitary 4 mm diameter filling defect in the common duct compatible with non-obstructing choledocholithiasis and findings related to known interstitial pancreatitis.On (b)(6) 2022, the patient was hospitalized and received intravenous (iv) antibiotic(details unspecified) along with fluids and potassium.On (b)(6) 2022, patient underwent an endoscopic surgery for removal of blockage in the common bile duct.On (b)(6) 2022,the patient had a cholecystectomy (laparoscopic removal of gallbladder) and did not receive any other treatment.On (b)(6) 2022,the patient was discharged from hospital.It was reported that there was unlikely suspicion that plenity might have contributed to the event.The patient will hold plenity for 3 weeks until she recovers from surgery and pancreatitis.She might restart at that time as long as no new symptoms or persistent symptoms.Action taken with plenity was reported as temporarily withdrawn.The outcome of the events biliary obstruction and pancreatitis acute was resolving at the time of this report.It was reported as other factors might be associated with the events.This case was verified by a healthcare professional.Company comment: this spontaneous report was reported by a ro physician regarding a 47-year-old female patient who experienced bile duct obstruction and acute pancreatitis while on plenity for an unknown indication.The patient¿s surgical history includes obstructive sleep apnea s/p surgery, uvula repair, deviation septum, tonsillectomy, 2 c-section, lumbar laminectomy, and appendectomy; and concomitant medications include junel fe, venlafaxine and multivitamin.The adverse event started 3 days after plenity therapy.This case is assessed as serious as the patient was hospitalized to undergo endoscopic surgery for bile duct blockage and cholecystectomy (for intervention).The causality for the events is assessed as unlikely due to lack of pharmacological plausability and the common causes of pancreatitis being gall stone, heavy alcohol intake and other systemic causes like hereditary pancreatitis, hypercalcemia and autoimmune.

• 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: 14488912
• MDR Text Key: 294787366
• Report Number: 3012121187-2022-00081
• 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: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• 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
• 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: VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE),
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 94 KG