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

Model Number B-50012

Device Problem Difficult to Remove (1528)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

Initial medwatch submitted to the fda on 08/apr/2021.A risk review of the labeling notes the following: the current orbera365¿ intragastric balloon system directions for use (dfu) addresses the known and anticipated potential event of "device appearance - post operative", "surgical related observation/complication" and "obstruction" as follows: 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.The risk of balloon deflation and intestinal obstruction (and therefore possible death related to intestinal obstruction) may be higher when balloons are left in place longer than 12 months or used at larger volumes (greater than 700 cc).Some obstructions have required surgical removal.Some obstructions have reportedly been associated with patients with diabetes or who have had prior abdominal surgery, so this should be considered in assessing the risk of the procedure.Bowel obstructions can result in surgical treatment or death.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.In preparation for removal, some patients may have retained contents in the stomach.Some patients may have clinically significant delay in gastric emptying and refractory intolerance to the balloon, necessitating early removal, and possibly leading to other adverse events.These patients may be at higher risk of aspiration upon removal and/or upon administration of anesthesia.The anesthesia team should be alerted to the risk for aspiration in these patients.Caution: balloon deflation and intestinal obstruction (and therefore possible death related to intestinal obstruction) has been experienced.While the potential for balloon deflation may increase over time, no correlation between balloon deflation and placement time has been observed.Possible complications of the use of the orbera365¿ system include: intestinal obstruction by the balloon.An insufficiently inflated balloon or a leaking balloon that has lost sufficient volume may be able to pass from the stomach into the small bowel.It may pass all the way through into the colon and be passed with stool.However, if there should be a narrow area in the bowel, as might occur after prior surgery on the bowel or adhesion formation, the balloon may not pass and then may cause a bowel obstruction.If this occurs, percutaneous drainage, surgery or endoscopic removal could be required.Esophageal obstruction.Once the balloon has been inflated in the stomach, the balloon could be pushed back into the esophagus.If this occurs, surgery or endoscopic removal could be required.

Event Description

The balloon got stuck in patients esophagus during balloon removal.Patient was transported to a hospital to have their balloon removed under full anesthesia and intubation.

• Brand Name: ORBERA365 INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• 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 ; CS
• Manufacturer Contact: david hooper ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 11638205
• MDR Text Key: 244628912
• Report Number: 3006722112-2021-00026
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020725
• UDI-Public: (01)10811955020725(17)2021-11-26(10)AF03371
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2021

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?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/26/2021
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF03371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2019
• 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; Required Intervention
• Patient Age: 32 YR
• Patient Weight: 59