MAUDE Adverse Event Report: GELESIS, INC. PLENITY; DELIVERY SYSTEM

Model Number MC0420

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

No lot num provided investigation closed.

Event Description

Bowel obstruction [intestinal obstruction].Case narrative: this is a spontaneous report, received from the united states of america initially reported by a physician on (b)(6) 2020 and (b)(6) 2020.A (b)(6) female patient of weight (b)(6) experienced bowel obstruction requiring hospitalization while on plenity for an unknown indication.The patient¿s medical history was reported as "htn and osa", (hypertension and obstructive sleep apnea (osa)).The patient had no history of surgeries.The patient¿s concomitant medications were not reported.On (b)(6) 2020, the patient was evaluated for plenity and started therapy at a dose of three capsules by mouth with 16 ounces (2 glasses) of water 20-30 minutes before lunch and dinner for an unknown indication.The lot number and expiry date were not reported.On an unknown date in 2020, the patient experienced bowel obstruction (pt: intestinal obstruction) and was hospitalized.The underlying cause for the event was unknown.The diagnostic tests were not reported for the event.On (b)(6) 2020, treatment with plenity was cancelled.It was reported that no surgery was required and on an unknown date in (b)(6) 2020, the patient was discharged from the hospital.The patient was doing better after discharging from the hospital.The patient's gastrointestinal physician informed her that it was not likely plenity that caused her obstruction but it was just a coincidence that she started it around the same time she had bowel obstruction.At the time of this report, action taken with plenity was reported as withdrawn and the outcome of the event (bowel obstruction) was resolved.The reporter assessed the event was unlikely related to plenity.This case was verified by a healthcare professional.Company comment: this spontaneous report by a physician concerns a (b)(6) female patient who was reported to be hospitalized for bowel obstruction (pt: intestinal obstruction) while on treatment with plenity.Patient weighed (b)(6) and had medical history reported as htn, osa (hypertension, obstructive sleep apnea) with no history of surgeries in the past.Patient was evaluated for plenity treatment on (b)(6) 2020 and treatment with plenity was cancelled on (b)(6) 2020.Concomitant medications, start date of plenity, duration of treatment with plenity, date of onset of bowel obstruction, hospital admission and discharge dates, underlying cause for bowel obstruction, clinical course in the hospital, and treatment provided were not reported.No surgery was required for the event, but patient was reported to have recovered from the event since discharge.The event was considered serious as it required hospitalization.In a follow up update, it was reported that the gi physician felt the bowel obstruction was unlikely related to plenity, however, that start of plenity treatment coincided with the event bowel obstruction, thus, acknowledging a plausible temporal relationship.Based on plausible temporal relationship and lack of information on other possible confounding factors, the causality of bowel obstruction to plenity is continued to be assessed as possibly related.

• Brand Name: PLENITY
• Type of Device: DELIVERY SYSTEM
• Manufacturer (Section G): GELESIS, INC.; 501 boylston street, suite 610; 2; boston MA 02116
• Manufacturer Contact: via verdi, 188 calimera (le); puglia, it 73021
• MDR Report Key: 11013570
• MDR Text Key: 225173234
• Report Number: 3012121187-2020-00025
• Device Sequence Number: 1
• Product Code: QFQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 12/15/2020

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 Model Number: MC0420
• Device Catalogue Number: MC0420
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 95