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

Model Number B-4800

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 15/jun/2022.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 ulcer; hemorrhage; and vessel damage / bleeding 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.The physiological response of the patient to the presence of orbera 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, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.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.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).It is important to discuss all possible complications and adverse events with your patient.Complications that may result from the use of this product include the risks associated with the medications and methods utilized in the endoscopic procedure, the risks associated with any endoscopic procedure, the risks associated with the orbera intragastric balloon specifically, and the risks associated with the patient's degree of intolerance to a foreign object placed in the stomach.Possible complications: 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.Abdominal or back pain, either steady or cyclic gastroesophageal reflux.Insufficient or no weight loss.Additional information: we are waiting to hear back from doctor to see if it a ulcer.Will update on supplement report.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.

Event Description

After 72 hours of balloon implant, patient vomiting blood after taken asprin.

• Brand Name: ORBERA¿ INTRAGASTRIC BALLOON SYSTEM
• Type of Device: 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; building b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: david hooper ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5128523757
• MDR Report Key: 14695028
• MDR Text Key: 295810407
• Report Number: 3006722112-2022-00053
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2022

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-4800
• Device Catalogue Number: B-4800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/15/2022
• 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 Outcome(s): Required Intervention
• Patient Sex: Female