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 03/23/2023

Event Type  Injury  

Event Description

Small intestine blockage [small intestinal obstruction] case narrative: this initial spontaneous report was received from the united states of america reported by a physician on (b)(6) 2023.A 61-years-old female patient (weight: 187 lbs) experienced small intestine obstruction while on plenity for weight management.The patient¿s initial weight was 200 lbs; current conditions included: hypertension, high cholesterol, obstructive sleep apnea, gerd/acid reflux, bile duct cancer (recession 2021); procedure included: chemotherapy (approximately 1 year previously from (b)(6) 2023), cancer surgery, 3 previous shoulder and hand surgeries (2019-2021), 2 previous back surgeries (2010), left knee surgery (2004), cholecystectomy, does not eat pork products due to beliefs but decided to start plenity despite knowing that pork byproducts are in capsules; allergy to tetanus, valium and penicillin; no usage of other medical devices was reported.The patient¿s concomitant medications included: entecavir, lisinopril, hydrochlorothiazide, atorvastatin, astropen (ibuprofen), zolpidem, pantoprazole.On (b)(6) 2023, the patient started therapy with plenity (lot number: a22046b1) 0.75g, at a dose of 3 capsules, orally, twice daily, 20 to 30 minutes before lunch and dinner with 16 oz of water for weight management.On (b)(6) 2023, after taking plenity the patient experienced small intestine blockage (pt: small intestinal obstruction) and was hospitalized on the same day.The physician treated the patient with pain medications.Also inserted a tube through the nose to the back of the throat, all the way to the stomach in order to suck out everything that was causing the blockage and left the tube in place for two days while monitoring, but surgery was not an option.On the same day, after hospitalization and medical intervention, small intestinal obstruction was disappeared.On (b)(6) 2023, the patient took the last dose of plenity and did not restart due to the severity of symptoms.On (b)(6) 2023, the patient canceled their plenity subscription.On (b)(6) 2023, the patient was discharged from the hospital.It was reported that the patient had a history of gerd/acid reflux and bile duct cancer, which may have contributed to this event.Action taken: the patient discontinued plenity due to the event of small intestinal obstruction.The outcome of the event, small intestinal obstruction, was resolved.This case is assessed as serious given the need for hospitalization and medical intervention required for the event small intestinal obstruction this case was verified by a healthcare professional.Company comment: this spontaneous report refers to a 61-years-old female patient who developed small intestinal obstruction while on plenity for weight management.Current conditions included hypertension, high cholesterol, obstructive sleep apnea, gerd/acid reflux, bile duct cancer (recession 2021); procedure included: chemotherapy (approximately 1 year previously from (b)(6) 2023), cancer surgery, 3 previous shoulder and hand surgeries (2019-2021), 2 previous back surgeries (2010), left knee surgery (2004), cholecystectomy; allergy to tetanus, valium, and penicillin.The patient does not eat pork products due to beliefs but decided to start plenity despite knowing that pork byproducts are in capsules.The patient developed small intestine blockage a week after starting plenity and was hospitalized.She was given pain and medical intervention was performed (inserted a tube through nose to the back of throat, all the way to the stomach to suck out everything that was causing the blockage and left the tube in place for two days while monitoring).The event resolved and she was discharged from the hospital after two days.Plenity was discontinued.This case is assessed as serious given the need for hospitalization and medical intervention required for the event small intestinal obstruction.Based on the reasonable temporal relationship, allergic history, and history of gerd/acid reflux and bile duct cancer that can act as confounders, the causality is assessed as possible.

Event Description

Small intestine blockage [small intestinal obstruction].Case narrative: this initial spontaneous report was received from the united states of america reported by a physician on 23-mar-2023.A 61-years-old female patient (weight: 187 lbs) experienced small intestine obstruction while on plenity for weight management.The patient¿s initial weight was 200 lbs; current conditions included: hypertension, high cholesterol, obstructive sleep apnea, gerd/acid reflux, heartburn, bile duct cancer (recession 2021); procedure included: chemotherapy (approximately 1 year previously from (b)(6) 2023), cancer surgery, 3 previous shoulder and hand surgeries (2019-2021), 2 previous back surgeries (2010), left knee surgery (2004), cholecystectomy, does not eat pork products due to beliefs but decided to start plenity despite knowing that pork byproducts are in capsules; allergy to tetanus, valium and penicillin; no usage of other medical devices was reported.The patient¿s concomitant medications included: entecavir, lisinopril, hydrochlorothiazide, atorvastatin, astropen (ibuprofen), zolpidem, pantoprazole.On (b)(6) 2023, the patient started therapy with plenity (lot number: a22046b1; expiry date: 15-aug-2023) 0.75g, at a dose of 3 capsules, orally, twice daily, 20 to 30 minutes before lunch and dinner with 16 oz of water for weight management.On (b)(6) 2023, the patient experienced severe stomach pain after taking plenity and was admitted to the hospital via emergency room.She had felt hardness in her stomach days before and assumed it was normal because the pills made her feel full.On (b)(6) 2023, the patient took the last dose of plenity and did not restart due to the severity of symptoms.On (b)(6) 2023, the patient's doctor confirmed that she experienced small intestine blockage (pt: small intestinal obstruction) and was hospitalized on same day.The physician treated the patient with pain medications like dilaudid.Also inserted a tube through the nose to the back of the throat, all the way to the stomach in order to suck out everything that was causing the blockage and left the tube in place for two days while monitoring, but surgery was not an option and ct scan were done.It was reported that the patient had never experienced any episodes of obstruction or blockage of any kind in the past.On the same day, after hospitalization and medical intervention, small intestinal obstruction was disappeared.On (b)(6) 2023, the patient canceled their plenity subscription.On (b)(6) 2023, the patient was discharged from the hospital.It was reported that the patient had a history of gerd/acid reflux and bile duct cancer, which may have contributed to this event.Action taken: the patient discontinued plenity due to the event of small intestinal obstruction.The outcome of the event, small intestinal obstruction, was resolved.This case is assessed as serious given the need for hospitalization and medical intervention required for the event small intestinal obstruction.This case was verified by a healthcare professional.Follow up information received on 16-apr-2023 included: plenity expiry date, current condition, treatment medications and symptoms of event and event related information were updated and narrative amended accordingly.Company comment: this spontaneous report refers to a 61-years-old female patient who developed small intestinal obstruction while on plenity for weight management.Current conditions included hypertension, high cholesterol, obstructive sleep apnea, gerd/acid reflux, heart burn, bile duct cancer (recession 2021); procedure included: chemotherapy (approximately 1 year previously from 10-jan-2023), cancer surgery, 3 previous shoulder and hand surgeries (2019-2021), 2 previous back surgeries (2010), left knee surgery (2004), cholecystectomy; allergy to tetanus, valium, and penicillin.The patient does not eat pork products due to beliefs but decided to start plenity despite knowing that pork byproducts are in capsules.The patient experienced hardness in her stomach a few days before and assumed it was normal because the pills made her feel full.Later, she developed severe pain in the stomach and was admitted in emergency room and a diagnosis of small intestine blockage was established (approximately a week after starting plenity) and was hospitalized.She was given pain medication dilaudid and medical intervention was performed (inserted a tube through nose to the back of throat, all the way to the stomach to suck out everything that was causing the blockage and left the tube in place for two days while monitoring).The gi doctor felt the pills had caused the intestinal obstruction.The event resolved and she was discharged from the hospital after two days.Plenity was discontinued.This case is assessed as serious given the need for hospitalization and medical intervention required for the event small intestinal obstruction.Based on the reasonable temporal relationship, allergic history, and history of gerd/acid reflux and bile duct cancer that can act as confounders, the causality is assessed as possible.

Event Description

Small intestine blockage [small intestinal obstruction] case narrative: this initial spontaneous report was received from the united states of america reported by a physician on (b)(6) 2023.A 61-years-old female patient (weight: 187 lbs) experienced small intestine obstruction while on plenity for weight management.The patient¿s initial weight was 200 lbs; current conditions included: hypertension, high cholesterol, obstructive sleep apnea, gerd/acid reflux, heartburn,perihilar cholangiocarcinoma; procedure included: chemotherapy (approximately 1 year previously from (b)(6) 2023), 3 previous shoulder and hand surgeries (2019-2021), 2 previous back surgeries (2010), left knee surgery (2004), cholecystectomy, r0 resection for a t3n0m0 lesion, does not eat pork products due to beliefs but decided to start plenity despite knowing that pork byproducts are in capsules; allergy to tetanus, valium and penicillin; no usage of other medical devices was reported.It was reported that the patient had a strong family history of pancreatic and breast cancer.The patient¿s concomitant medications included: entecavir, lisinopril, hydrochlorothiazide, atorvastatin, astropen (ibuprofen), zolpidem, pantoprazole.On (b)(6) 2023, the patient started therapy with plenity (lot number: a22046b1; expiry date: 15-aug-2023) 0.75g, at a dose of 3 capsules, orally, twice daily, 20 to 30 minutes before lunch and dinner with 16 oz of water for weight management.On (b)(6) 2023, the patient experienced severe stomach pain, post lunch shortly after taking plenity and was admitted to the hospital via emergency room and imaging showed a high -grade obstruction.She had felt hardness in her stomach days before and assumed it was normal because the pills made her feel full.On (b)(6) 2023, the patient took the last dose of plenity and did not restart due to the severity of symptoms.On (b)(6) 2023, the patient's doctor confirmed that she experienced small intestine blockage (pt: small intestinal obstruction) and was hospitalized on same day.The physician treated the patient with pain medications like dilaudid.Also inserted a ng decompression tube through the nose to the back of the throat, all the way to the stomach in order to suck out everything that was causing the blockage and left the tube in place for two days while monitoring, but surgery was not an option and ct scan were done.It was reported that the patient had never experienced any episodes of obstruction or blockage of any kind in the past.On the same day, after hospitalization and medical intervention, small intestinal obstruction was disappeared.On (b)(6) 2023, the patient canceled their plenity subscription.On (b)(6) 2023, the patient was discharged from the hospital.It was reported that the patient had a history of gerd/acid reflux and bile duct cancer, which may have contributed to this event.Action taken: the patient discontinued plenity due to the event of small intestinal obstruction.The outcome of the event, small intestinal obstruction, was resolved.The patient was symptom-free since that time.This case is assessed as serious given the need for hospitalization and medical intervention required for the event small intestinal obstruction.This case was verified by a healthcare professional.Follow up information received on 16-apr-2023 included: plenity expiry date, current condition, treatment medications and symptoms of event and event related information were updated and narrative amended accordingly.Follow up information received on 19-may-2023 included: patient¿s past family medical history, past medical history, lab test, procedure and narrative amended accordingly.Company comment: this spontaneous report refers to a 61-years-old female patient who developed small intestinal obstruction while on plenity for weight management.Current conditions included hypertension, high cholesterol, obstructive sleep apnea, gerd/acid reflux, heart burn, perihilar cholangiocarcinoma (recession 2021); procedures included: chemotherapy (approximately 1 year previously from (b)(6) 2023), ro resection for a t3n0m0 lesion, 3 previous shoulder and hand surgeries (2019-2021), 2 previous back surgeries (2010), left knee surgery (2004), cholecystectomy; allergy to tetanus, valium, and penicillin.The patient does not eat pork products due to beliefs but decided to start plenity despite knowing that pork byproducts are in capsules.The patient experienced hardness in her stomach a few days before and assumed it was normal because the pills made her feel full.Later, she developed severe pain in the stomach post lunch shortly after taking plenity and was admitted in emergency room and a diagnosis of small intestine blockage was established (approximately a week after starting plenity) and was hospitalized.She was given pain medication dilaudid and medical intervention was performed (inserted an ng tube through nose to the back of throat, all the way to the stomach to suck out everything that was causing the blockage and left the tube in place for two days while monitoring).The gi doctor felt the pills had caused the intestinal obstruction.The event resolved and she was discharged from the hospital after two days.Plenity was discontinued.This case is assessed as serious given the need for hospitalization and medical intervention required for the event small intestinal obstruction.Based on the reasonable temporal relationship, allergic history, and history of gerd/acid reflux and perihilar cholangiocarcinoma that can act as confounders, the causality is assessed as possible.

• 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: 16782600
• MDR Text Key: 313707097
• Report Number: 3012121187-2023-00008
• 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: 06/05/2023

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 Expiration Date: 08/15/2023
• Device Model Number: MC0420
• Device Lot Number: A22046B1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/04/2023; 06/05/2023
• 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
• Treatment: ASTROPEN (IBUPROFEN),; ASTROPEN (IBUPROFEN).; ASTROPEN (IBUPROFEN).; ATORVASTATIN (ATORVASTATIN).; ATORVASTATIN (ATORVASTATIN).; ATORVASTATIN (ATORVASTATIN).; ENTECAVIR (ENTECAVIR).; ENTECAVIR (ENTECAVIR).; ENTECAVIR (ENTECAVIR).; HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE).; HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE).; HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE).; LISINOPRIL (LISINOPRIL).; LISINOPRIL (LISINOPRIL).; LISINOPRIL (LISINOPRIL).; PANTOPRAZOLE (PANTOPRAZOLE).; PANTOPRAZOLE (PANTOPRAZOLE).; PANTOPRAZOLE (PANTOPRAZOLE).; ZOLPIDEM (ZOLPIDEM).; ZOLPIDEM (ZOLPIDEM).; ZOLPIDEM (ZOLPIDEM).
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 85 KG