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

Model Number B-40800

Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250); Unintended Deflation (4061)

Patient Problem Failure of Implant (1924)

Event Date 10/10/2022

Event Type  malfunction  

Event Description

Balloon was deflated.Removed successfully.

Manufacturer Narrative

Initial medwatch submitted to the fda on 14/dec/2022.A review of the device labeling notes the following: the orbera intragastric balloon system is indicated for use as an adjunct to weight reduction for adults with obesity with body mass index (bmi) of 30 and 40 kgm2 and is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of significant long-term weight loss and maintenance of that weight loss.Orbera is indicated for adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs.The maximum placement period for orbera is 6 months.The current orbera365¿ intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "deflation, vomiting and early removal "as follows: "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, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms." "complications: possible complications of the use of the orbera365¿ system include: gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.Patients reporting loss of satiety, increased hunger and/or weight gain should be examined endoscopically as this is indicative of an igb deflation.A patient who's deflated (i.E.Collapsed) igb has moved into the intestines must be monitored closely for an appropriate period of time (at least 2 weeks) to confirm its uneventful passage through the intestine.Abdominal or back pain, either steady or cyclic.Deflation and subsequent replacement." deflated device should be removed promptly.Possible adverse events: intestinal obstruction by the igb.An insufficiently filled igb or a leaking igb that has lost sufficient volume may be able to pass from the stomach into the small bowel.It may pass all the way into the colon and be passed with stool.However, if there is a narrow area in the bowel or adhesion formation, which may occur after previous surgery on the bowel, the igb may not pass and could cause a bowel obstruction.If this occurs, surgery or endoscopic removal could be required.Insufficient or no weight loss.Igb deflation (i.E.Collapse) and subsequent replacement.Additional information: the device has not been returned for analysis.The investigator determined that a device history record (dhr) review is required for this complaint, as there are previous other similar complaints against this lot number, af04856 and allegation.A device history record (dhr) review was completed.The subject product met all specifications and requirements in effect at the time of manufacture.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: ORBERA 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: david hooper ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5128523757
• MDR Report Key: 15977578
• MDR Text Key: 307894557
• Report Number: 3006722112-2022-00116
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020510
• UDI-Public: (01)10811955020510(17)20240104(10)AF04856
• 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,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2024
• Device Model Number: B-40800
• Device Catalogue Number: B-40800
• Device Lot Number: AF04856
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2022
• Date Device Manufactured: 01/04/2022
• 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 Weight: 82 KG