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

Model Number	B-4800
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	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient did not feel the balloon.Confirmed bt x-ray the balloon deflated.Balloon was removed successfully.
Additional 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 "deflation, vomiting and early removal "as follows: "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, 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 orbera¿ 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 device history record (dhr) review is pending for reporting purposes.There were no other complaints in the apollo database against this lot number, af04709.
Additional Manufacturer Narrative
Supplement #x medwatch submitted to the fda on 26/jul/2022.A device history record (dhr) review was performed for reporting purposes.The subject product met all specifications and requirements in effect at the time of manufacture.There were no other complaints in the apollo database against this lot number, af04709.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 07/july/2022.A deflated balloon with green coloration was returned for evaluation.An air leak test was conducted, and the shell slowly deflated due to a small slit on the shell.Under microscopic analysis, the small slit has jagged edges which is consistent with a surgical instrument for removal purposes.The valve was submerged in water and there were bubbles coming from the valve.Under microscopic analysis, there is unknown particles present inside the slit valve.The complaint has been verified as more than likely the unknown particles prevented proper closer of the slit valve.

• 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; 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: 14695642
• Report Number: 3006722112-2022-00049
• Device Sequence Number: 20209606
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: (01)10811955020619(17)20230831(10)AF04709
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P140008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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): 05/19/2022

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: 08/31/2023
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Device Lot Number: AF04709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 114 KG