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

Model Number	B-4800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Vomiting (2144); Aspiration Pneumonitis (4455)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Healthcare professional reported patient admitted to the hospital after complaining of black stool and possible gi bleed on an unknown event date.Endoscopic exam identified 1.5 liters of fluid and food which were removed.X-ray identified aspiration pneumonia.Delayed gastric emptying was also diagnosed.Patient discharged from hospital.
Additional Manufacturer Narrative
Initial medwatch submitted to the fda on 05/08/2023.A review of the device labeling notes the following: risk review verbiage less last including labeling and monitoring.The current orbera¿ intragastric balloon system directions for use (dfu) addresses the known and anticipated potential physiological events of vomiting and delayed gastric emptying 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 orbera¿ 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 orbera¿ 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 orbera¿ 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 not possible for this complaint, as the device serial and lot number are currently unknown.
Additional Manufacturer Narrative
Supplement #01 medwatch submitted to the fda on 27/jun/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, af04883.The subject product met all specifications and requirements in effect at the time of manufacture.There was one other complaint in the apollo database against this lot number.Device evaluation summary: assessment of the device involved in this complaint was not possible as the balloon is still implanted, and it has not been possible to determine the root cause for this event.

• Brand Name: ORBERA¿ INTRAGASTRIC BALLOON SYSTEM
• Common Device Name: INTRAGASTRIC BALLOON SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg. 1 ste. 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; bldg b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: adriana russell ; 1120 s. capital of texas hwy; bldg. 1 ste. 300; austin, TX 78746 ; 5122795114
• MDR Report Key: 16875522
• Report Number: 3006722112-2023-00083
• Device Sequence Number: 17988247
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: (01)10811955020619(17)20240121(10)AF04883
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2024
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Device Lot Number: AF04883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 113 KG