MAUDE Adverse Event Report: GELESIS SRL PLENITY; DELIVERY SYSTEM

Model Number MC0684

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.

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 (b)(6) physician on 03-may-2022.A 47-year-old female patient (weight: 207 lbs) experienced bile duct obstruction, acute pancreatitis while on plenity for obesity (weight loss).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.It was confirmed that the patient had no past history of gall stones, pancreatitis or similar episodes and also confirmed that, there were no familial history of pancreatitis or medical history of diabetes were present.It was reported that the patient usually took 2 alcohol drinks on the weekend.On (b)(6) 2022, the patient started therapy with plenity(lot number: a21315b1, expiration date: 11-may-2023, reference number: (b)(4) at a dose of three capsules (0.75g), twice daily, for obesity (weight loss).The patient took plenity in combination with diet and exercise.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, plenity was discontinued and 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 events.The patient thought of holding plenity for 3 weeks until she recovers from surgery and pancreatitis, but did not restarted it.Action taken: patient discontinued plenity as a result of events.The outcome of the events biliary obstruction and pancreatitis acute was resolving.It was reported that other factors might be associated with the events.This case was verified by a healthcare professional.Follow-up information received on 07-jun-2022 included: lot number, expiry date, model number, reference number, dose, indication, confirmation regarding no history of gallstone, pancreatitis and no familial history of pancreatitis and diabetes were updated.Narrative updated accordingly.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 obesity.The patient¿s medical history include alcohol consumption and 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 (intervention done).The causality for the events is assessed as unlikely due to lack of pharmacological plausability and the cause of pancreatitis being gall stones and alcohol intake in the current case.Follow-up information does not alter the causality and listedness assessment and they were retained as per previous assessment.

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 weight management.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.It was confirmed that the patient had no past history of gall stones, pancreatitis or similar episodes and also confirmed that, there were no familial history of pancreatitis or medical history of diabetes were present.It was reported that the patient usually took 2 alcohol drinks on the weekend.On (b)(6) 2022, the patient started therapy with plenity(lot number: a21315b1, expiration date: 11-may-2023, reference number: (b)(4) at a dose of three capsules (0.75g), twice daily, for weight management.The patient took plenity in combination with diet and exercise.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, plenity was discontinued and 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 events biliary obstruction, pancreatitis were recovered and the patient was discharged from hospital.It was reported that there was unlikely suspicion that plenity might have contributed to the events, however, other factors might be associated with the events.The patient thought of holding plenity for 3 weeks until she recovers from surgery and pancreatitis, but did not restarted it.The patient stated that she was recovering from her surgery.Action taken: patient discontinued plenity as a result of events.Outcome of the events biliary obstruction and pancreatitis acute was reported as resolved.This case was verified by a healthcare professional.Follow-up information received on 07-jun-2022 included: lot number, expiry date, model number, reference number, dose, indication, confirmation regarding no history of gallstone, pancreatitis and no familial history of pancreatitis and diabetes were updated.Narrative updated accordingly.Follow up information received on 06-jul-2022 included: confirmation regarding recovering from surgery, the stop date of the events and final outcome of the events were updated.Narrative amended accordingly.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 obesity.The patient's medical history include alcohol consumption and 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 (intervention done).The causality for the events is assessed as unlikely due to lack of pharmacological plausability and the cause of pancreatitis being gall stones and alcohol intake in the current case.Follow-up information does not alter the causality and listedness assessment and they were retained as per previous assessment.

• 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: 14490064
• MDR Text Key: 294787604
• Report Number: 3012121187-2022-00082
• 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,Followup,Followup
• 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 Expiration Date: 05/11/2023
• Device Model Number: MC0684
• Device Lot Number: A21315B1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/17/2022; 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: VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE),; VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE),; VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE),
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Sex: Female
• Patient Weight: 94 KG