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

Model Number	B-50012
Medical Device Problem Codes	Deflation Problem (1149); Fluid/Blood Leak (1250); Unintended Deflation (4061)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 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.A previous dhr review was completed for lot number, af04709.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.
Event or Problem Description
Patient noticed urine wa green coloring.Contact doctor and an endoscopy was performed and it was found that the balloon was deflated.Balloon was removed successfully and new balloon was implanted.
Additional Manufacturer Narrative
Supplement #01 medwatch submitted to the fda on 20/apr/2023.Additional information: the device has not been returned for analysis.A previous dhr review was completed for lot number, af04709 (ccn0007725).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, and it has not been possible to determine the root cause for this event.

• Brand Name: ORBERA365¿ INTRAGASTRIC BALLOON SYSTEM
• Common Device Name: 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 ; 5122795411
• MDR Report Key: 16284328
• Report Number: 3006722112-2023-00019
• Device Sequence Number: 11951438
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: (01)10811955020619(17)20230831(10)AF04709
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: P140008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2022
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF04709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 83 KG