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 Foreign Body In Patient (2687)

Event Date 07/11/2022

Event Type  Injury  

Event Description

Plenity capsule got stuck in throat and the patient was unable to move the capsule on her own/ crystals in her esophagus [foreign body in throat].This initial spontaneous report was received from the united states of america via physician on 14-jul-2022.A 59-year-old female patient (weight: 169 lbs) reported medication stuck in throat while on plenity for an unknown indication.The patient¿s current conditions included diabetes; past history of swallowing difficult, procedure included: hysterectomy, tubal ligation; concomitant medications included zafirlukast; drug allergies and usage of other medical devices were not reported.On (b)(6) 2022, the patient started therapy with plenity at a dose of 0.75 g, twice daily, 20 minutes before two largest meals of the day for unknown indication.Lot number and expiry date of plenity were not reported.On (b)(6) 2022, the patient reported that the capsule got stuck in the throat after taking plenity dose before lunch and was unable to move the capsule on her own (pt: foreign body in throat).She was presented to emergency department, where it was successfully retrieved.She had issues with swallowing in the past, but not with the pills or capsules (patient did not relay this information before plenity was prescribed).It was reported that when the capsule was removed, crystals were present in the esophagus.Action taken: patient discontinued plenity due to event foreign body in throat.Outcome of the event foreign body in throat was resolved.The case is assessed as serious based on the need for medical intervention to remove the contents of the capsule in the emergency room.This case was verified by a healthcare professional.Company comment: this spontaneous report refers to a 59-year-old female patient who reported foreign body in throat while on plenity for an unknown indication.Medical history is significant for diabetes, past history of swallowing difficulty and procedures included: hysterectomy, tubal ligation.Concomitant medications included zafirlukast.The event occurred 4 months after starting plenity with the lunch dose.The patient reported that the capsule got stuck in her throat and was unable to move it on her own so she was taken to the er where it was retrieved and crystals were found in the esophagus.Plenity was discontinued due to the event.The case is assessed as serious based on the need for medical intervention to remove the contents of the capsule in the emergency room.Considering the plausible temporal association (events occurred approximately 4 months after start of plenity), spontaneous nature of the report, and past history of swallowing difficulty that can act as a confounder, the causality for the event foreign body in throat is assessed as possible with plenity.

Event Description

Plenity capsule got stuck in throat and the patient was unable to move the capsule on her own/ crystals in her esophagus [foreign body in throat].Case narrative: this initial spontaneous report was received from the united states of america via physician on 14-jul-2022.A 59-year-old female patient (weight: 169 lbs) reported medication stuck in throat while on plenity for weight management.The patient¿s current conditions included diabetes; past history of swallowing difficult, procedure included: hysterectomy, tubal ligation and esophageal dilatation; concomitant medications included zafirlukast; drug allergies and usage of other medical devices were not reported.On (b)(6) 2022, the patient started therapy with plenity (expiration date: 15-may-2023) at a dose of 0.75 g, twice daily, 20 minutes before two largest meals of the day for weight management.Lot number of plenity was not reported.On (b)(6) 2022, the patient reported that the capsule got stuck in the throat after taking plenity dose before lunch and was unable to move the capsule on her own (pt: foreign body in throat).She presented to emergency department, where the plenity particles were successfully retrieved from the esophagus.She had issues with swallowing in the past, but not with the pills or capsules (patient did not relay this information before plenity was prescribed).It was reported that when the capsule was removed, particles were present in the esophagus.The patient stated this was the first time she experienced the episode of particles in esophagus after starting plenity and had no such similar episodes previously.Action taken: patient discontinued plenity due to event foreign body in throat.Outcome of the event foreign body in throat was resolved.The case is assessed as serious based on the need for medical intervention to remove the contents of the capsule in the emergency room.This case was verified by a healthcare professional.Follow up information received on 29-aug-2022 included: indication, medical history, expiry date of plenity, and confirmation of occurrence of the episode (particles in esophagus) as first, after starting plenity and confirmation of no such episodes have occurred in the past.Narrative amended accordingly.Company comment: this spontaneous report refers to a 59-year-old female patient who reported foreign body in throat while on plenity for weight management.Medical history is significant for diabetes, past history of swallowing difficulty and procedures included: hysterectomy, tubal ligation and esophageal dilatation.Concomitant medications included zafirlukast.The event occurred 4 months after starting plenity with the lunch dose.This was the first episode after starting plenity and patient reported that the capsule got stuck in her throat and was unable to move it on her own, so she was taken to the er where the plenity capsule and particles were retrieved from the esophagus.Plenity was discontinued due to the event.The case is assessed as serious based on the need for medical intervention to remove the contents of the capsule in the emergency room.Considering the plausible temporal association (events occurred approximately 4 months after start of plenity), spontaneous nature of the report, and past history of swallowing difficulty that can act as a confounder, the causality for the event foreign body in throat is assessed as possible with plenity.Follow-up information doesn¿t change the medical assessment of the case.

Event Description

Plenity capsule got stuck in throat and the patient was unable to move the capsule on her own/ crystals in her esophagus [foreign body in throat] case narrative: this initial spontaneous report was received from the united states of america via physician on (b)(6) 2022.A 59-year-old female patient (weight: 169 lbs) reported medication stuck in throat while on plenity for weight management.The patient¿s current conditions included diabetes; past history of swallowing difficult, procedure included: hysterectomy, tubal ligation and esophageal dilatation; concomitant medications included zafirlukast; drug allergies and usage of other medical devices were not reported.On (b)(6) 2022, the patient started therapy with plenity (expiration date: 15-may-2023) at a dose of three 0.75 g, twice daily, 20 minutes before two largest meals of the day for weight management.Lot number of plenity was not reported.On (b)(6) 2022, the patient reported that the capsule got stuck in the throat after taking plenity dose before lunch and was unable to move the capsule on her own (pt: foreign body in throat).She presented to emergency department on the same day, where the plenity particles were successfully retrieved from the esophagus.She had issues with swallowing in the past, but not with the pills or capsules (patient did not relay this information before plenity was prescribed).There was no hospitalization reported.It was reported that when the capsule was removed with endoscopy, particles were present in the esophagus.No follow up was scheduled for evaluation of the crystals these were removed at the same time as the capsule.The patient stated this was the first time she experienced the episode of particles in esophagus after starting plenity and had no such similar episodes previously.The patient did not disclose information regarding diet, exercise and rationale for performing esophageal dilatation in the past.Action taken: patient discontinued plenity due to event foreign body in throat.Outcome of the event foreign body in throat was resolved.The case is assessed as serious based on the need for medical intervention to remove the contents of the capsule in the emergency room.This case was verified by a healthcare professional.Follow up information received on (b)(6) 2022 included: indication, medical history, expiry date of plenity, and confirmation of occurrence of the episode (particles in esophagus) as first, after starting plenity and confirmation of no such episodes have occurred in the past.Narrative amended accordingly.Follow up information received on (b)(6) 2022 included: confirmation of er visit date, capsules removal by endoscopy.Narrative amended accordingly.Follow-up information received on (b)(6) 2022 included: plenity dose was updated.Narrative amended accordingly.Company comment: this spontaneous report refers to a 59-year-old female patient who reported foreign body in throat while on plenity for weight management.Medical history is significant for diabetes, past history of swallowing difficulty and procedures included: hysterectomy, tubal ligation and esophageal dilatation.Concomitant medications included zafirlukast.The event occurred 4 months after starting plenity with the lunch dose.This was the first episode after starting plenity and patient reported that the capsule got stuck in her throat and was unable to move it on her own, so she was taken to the er where the plenity capsule and particles were retrieved from the esophagus by endoscopy.Plenity was discontinued due to the event.The case is assessed as serious based on the need for medical intervention to remove the capsule and its contents in the emergency room (by endoscopy).Considering the plausible temporal association (events occurred approximately 4 months after start of plenity), spontaneous nature of the report, and past history of swallowing difficulty that can act as a confounder, the causality for the event foreign body in throat is assessed as possible with plenity.Follow-up information doesn¿t change the medical assessment of the case.

Event Description

Plenity capsule got stuck in throat and the patient was unable to move the capsule on her own/ crystals in her esophagus [foreign body in throat].Case narrative: this initial spontaneous report was received from the united states of america via physician on 14-jul-2022.A 59-year-old female patient (weight: 169 lbs) reported medication stuck in throat while on plenity for weight management.The patient¿s current conditions included diabetes; past history of swallowing difficult, procedure included: hysterectomy, tubal ligation and esophageal dilatation; concomitant medications included zafirlukast; drug allergies and usage of other medical devices were not reported.On (b)(6) -2022, the patient started therapy with plenity (expiration date: 15-may-2023) at a dose of 0.75 g, twice daily, 20 minutes before two largest meals of the day for weight management.Lot number of plenity was not reported.On (b)(6) 2022, the patient reported that the capsule got stuck in the throat after taking plenity dose before lunch and was unable to move the capsule on her own (pt: foreign body in throat).She presented to emergency department on the same day, where the plenity particles were successfully retrieved from the esophagus.She had issues with swallowing in the past, but not with the pills or capsules (patient did not relay this information before plenity was prescribed).There was no hospitalization reported.It was reported that when the capsule was removed with endoscopy, particles were present in the esophagus.No follow up was scheduled for evaluation of the crystals these were removed at the same time as the capsule.The patient stated this was the first time she experienced the episode of particles in esophagus after starting plenity and had no such similar episodes previously.Action taken: patient discontinued plenity due to event foreign body in throat.Outcome of the event foreign body in throat was resolved.The case is assessed as serious based on the need for medical intervention to remove the contents of the capsule in the emergency room.This case was verified by a healthcare professional.Follow up information received on 29-aug-2022 included: indication, medical history, expiry date of plenity, and confirmation of occurrence of the episode (particles in esophagus) as first, after starting plenity and confirmation of no such episodes have occurred in the past.Narrative amended accordingly.Follow up information received on 21-sep-2022 included: confirmation of er visit date, capsules removal by endoscopy.Narrative amended accordingly company comment: this spontaneous report refers to a 59-year-old female patient who reported foreign body in throat while on plenity for weight management.Medical history is significant for diabetes, past history of swallowing difficulty and procedures included: hysterectomy, tubal ligation and esophageal dilatation.Concomitant medications included zafirlukast.The event occurred 4 months after starting plenity with the lunch dose.This was the first episode after starting plenity and patient reported that the capsule got stuck in her throat and was unable to move it on her own, so she was taken to the er where the plenity capsule and particles were retrieved from the esophagus by endoscopy.Plenity was discontinued due to the event.The case is assessed as serious based on the need for medical intervention to remove the capsule and its contents in the emergency room (by endoscopy).Considering the plausible temporal association (events occurred approximately 4 months after start of plenity), spontaneous nature of the report, and past history of swallowing difficulty that can act as a confounder, the causality for the event foreign body in throat is assessed as possible with plenity.Follow-up information doesn¿t change the medical assessment of the case.

• 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: 15162371
• MDR Text Key: 297210553
• Report Number: 3012121187-2022-00740
• 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,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/18/2023
• 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: ZAFIRLUKAST (ZAFIRLUKAST).; ZAFIRLUKAST (ZAFIRLUKAST).; ZAFIRLUKAST (ZAFIRLUKAST).; ZAFIRLUKAST (ZAFIRLUKAST).
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 72 KG