MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC ORBERA INTRAGASTRIC BALLOON SYSTEM

Model Number B-40800

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

Patient Problems Fever (1858); Pain (1994)

Event Type  malfunction  

Event Description

Patient symptoms were fever and myalgia, and dehydration.Conservative treatment was instituted with rest and hydration and the patient had a good evolution.The balloon was removed late due to given patient to recover for a safe balloon removal.

Manufacturer Narrative

Initial medwatch submitted to the fda on 24/feb/2023.A review of the device labeling notes the following: the current orbera intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "fever; pain; and broken / damaged / defective component" are as follows: precautions: if difficulty with the igb placement catheter is noted during placement (e.G., resistance to igb filling), then the device should be removed and replaced with a new igb.To lessen, or prevent catheter defects, the catheter must remain slack during the filling process.If the catheter is under tension during this process, the tip of the catheter may dislodge from the igb, preventing further igb deployment.Warnings and precautions: proper positioning of the placement catheter assembly and the orbera intragastric balloon system within the stomach is necessary to allow proper inflation.Lodging of the balloon in the esophageal opening during inflation may cause injury and/or device rupture.The orbera intragastric balloon system is composed of soft silicone elastomer and is easily damaged by instruments or sharp objects.The balloon must be handled only with gloved hands and with the instruments recommended in this document.If the balloon becomes separated from the sheath prior to placement, do not attempt to use the balloon or reinsert the balloon into the sheath.During the filling process the fill tube must remain slack.If the fill tube is under tension during the intubation process, the fill tube may dislodge from the balloon, preventing further balloon deployment.Warning: patients must be advised that the igb is intended to be placed for 6 months maximally, at which point removal is required.Longer periods of igb placement increase the risk of igb deflation (a reduction in size of the device due to loss of saline) which can lead to intestinal obstruction and risk for death.The risk of these events is also significantly higher when igbs are filled to a larger volume than indicated (greater than 700cc).Warning: when filling the igb during the placement procedure, avoid rapid fill rates as these will generate high pressure which can damage the igb valve or cause premature detachment of the igb from the tip of the placement catheter.Death due to complications related to intestinal obstruction, gastric perforation, is possible.Pregnancy or breast-feeding contraindicates use of this device.Should pregnancy be confirmed at any time during the course of treatment, the device should be removed as soon as it is safely possible.Gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.Continuing nausea and vomiting.This could result from direct irritation of the lining of the stomach or as a result of the balloon blocking the outlet of the stomach.It is even theoretically possible that the balloon could prevent vomiting (not nausea or retching) by blocking the inlet to the stomach from the esophagus.Spontaneous over inflation of an indwelling balloon with symptoms including intense abdominal pain, swelling of the abdomen (abdominal distension) with or without discomfort, difficulty breathing, and/or vomiting.Patients experiencing any of these symptoms should be counseled to seek immediate care.Additional information: the device has not been returned for analysis.The investigator is waiting until the lot number of the device is known to determine whether a device history record (dhr) review is or is not required for this complaint.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. captail of texas hwy; bldg 1, ste 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: adriana russell ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795114
• MDR Report Key: 16439839
• MDR Text Key: 310279893
• Report Number: 3006722112-2023-00049
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B-40800
• Device Catalogue Number: B-40800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female