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

Model Number B-50012

Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250); Mechanical Problem (1384); Unintended Deflation (4061)

Patient Problem Failure of Implant (1924)

Event Date 10/20/2022

Event Type  malfunction  

Event Description

Patient experienced greenish color urine.A endoscopic was performed and it was noted that the balloon was fully deflated.Balloon was removed successfully.Patient is doing fine.

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 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, af04806 for (b)(4).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.

Manufacturer Narrative

Supplement # 1 medwatch submitted to the fda on 17/jan/2023.Additional information: a previous dhr review was completed for lot number, af04806 for (b)(4).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: the device was returned to the apollo device analysis laboratory on 28/nov/2022.A deflated balloon with blue coloration on the shell was returned.Under microscopic analysis, the small hole on the shell has rounded edges and rolls inward.Due to the small hole, functional evaluation of the device could not be conducted.The complaint has been verified as it is uncertain how the small hole was created as the shell rolls inward which is not consistent with a puncture from a surgical instrument.Lab analysis was able to replicate the reported event of "deflation", as there is a small hole on the shell.The user effect of "deflation" is known and labeled possible adverse event.

• Brand Name: ORBERA365¿ INTRAGASTRIC BALLOON SYSTEM
• Type of Device: 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: 15977592
• MDR Text Key: 308532100
• Report Number: 3006722112-2022-00117
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020725
• UDI-Public: (01)10811955020725(17)20231110(10)AF04806
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: 11/10/2023
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF04806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2021
• 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 Age: 58 YR
• Patient Sex: Female
• Patient Weight: 68 KG