MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC ORBERA365¿ INTRAGASTRIC BALLOON SYSTEM

Model Number B-50012

Device Problem Fluid/Blood Leak (1250)

Patient Problem Perforation of Esophagus (2399)

Event Date 01/30/2023

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 22/feb/2023.A review of the device labeling notes the following: the current orbera365¿ intragastric balloon system directions for use (dfu) addresses the known and anticipated potential event of esophageal perforation as follows: the igb is composed of a soft silicone elastomer and is easily damaged by instruments or sharp objects.The igb must be handled only with gloved hands and with the instruments recommended in this document.Each physician and patient should evaluate the risks associated with endoscopy and intragastric balloons (see complications below) and the possible benefits of a temporary treatment for weight loss prior to use of the orbera365¿ system.To prevent ulcers and control gastroesophageal reflux symptoms, it is recommended that the patient start a program of oral proton pump inhibitors (ppis) for approximately 3-5 days prior to igb placement so a maximal gastric acid suppression effect will be present on the day of placement.It is recommended that the ppi dose be given sublingually after igb placement if nausea and/or vomiting are present.A starting full dose daily regimen of an oral ppi should be continued as long as the igb is in place.Other medications that are started prophylactically should be continued after igb placement until they are no longer needed.Furthermore, subjects will be directed to avoid medications known to cause or exacerbate gastroduodenal mucosal damage.The risk of intestinal obstruction may be higher in patients who have had prior abdominal or gynecological surgery.The risk of intestinal obstruction may be higher in patients who have a dysmotility disorder or diabetes.The physiological response of the patient to the presence of the orbera365¿ system balloon may vary depending upon the patient's general condition and the level and type of activity.The types and frequency of administration of drugs or diet supplements and the overall diet of the patient may also affect the response.Each patient must be monitored closely during the entire term of treatment in order to detect the development of possible complications.Each patient should be instructed regarding symptoms of deflation, gastrointestinal obstruction, acute pancreatitis, spontaneous inflation, ulceration, gastric and esophageal perforation, and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Possible complications of the use of the orbera365¿ system include: 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.Patients with an igb that present with severe abdominal pain that have a negative endoscopy and x-ray may additionally require a ct scan to definitively rule out a perforation.Note that continued nausea and vomiting could result from direct irritation of the lining of the stomach, as a result of the balloon blocking the outlet of the stomach, or hyperinflation of the balloon.Additional information: the investigator determined that a device history record (dhr) review is required for this complaint due to the complaint being reportable.Dhr review was completed for lot number, af04523.The subject product met all specifications and requirements in effect at the time of manufacture.

Event Description

During placement of the balloon in was noted that the balloon was leaking and the doctor decided to exchange the balloon to a backup balloon, but during the removal of the balloon the esophageal wall was punctured and doctor decided not to place the backup as the wall was bleeding.The patient was admitted to the hospital for observation.

Manufacturer Narrative

Supplement #x medwatch submitted to the fda on 25/apr/2023.Additional information: the investigator determined that a device history record (dhr) review is required for this complaint due to the complaint being reportable.Dhr review was completed for lot number, af04523.The subject product met all specifications and requirements in effect at the time of manufacture.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 6/feb/2023.A deflated balloon with slits on the shell was returned.The fill tubing was returned, and the end of the fill tubing was returned cut; therefore, a sample fill tube was used for testing.The fill tip pressure to inflate the balloon met minimum requirements.An air leak test was conducted, and the shell slowly deflated due to a slit on the shell.Under microscopic analysis, the slit on the shell has jagged edges which is consistent with a surgical instrument for removal purposes.A syringe was used to push water down the fill tip on the returned fill tubing and there were no leaks observed at the fill tip and tube connection.The complaint could not be verified as there were no leaks observed.The leak on the shell was due to a surgical instrument for removal purposes.Lab analysis was not able to replicate the reported events of "esophageal perforation; difficulty adding/removing saline".It has not been possible to determine a root cause for this reported complaint.The user effects of "esophageal perforation; difficulty adding/removing saline" are known and labeled possible adverse event.

• Brand Name: ORBERA365¿ 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: 16418561
• MDR Text Key: 310331718
• Report Number: 3006722112-2023-00044
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020725
• UDI-Public: (01)10811955020725(17)20230309(10)AF04523
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

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: Health Professional
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF04523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/22/2023
• Supplement Dates Manufacturer Received: 01/30/2023
• Supplement Dates FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2023
• 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 Outcome(s): Hospitalization
• Patient Weight: 220 KG