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

Model Number B-50012

Device Problems Deflation Problem (1149); Unintended Deflation (4061)

Patient Problem Failure of Implant (1924)

Event Date 02/08/2022

Event Type  malfunction  

Event Description

The patient reported feeling lack of restriction in stomach.Endoscopic exam was performed and it was noted the balloon was deflated.Balloon was removed successfully.

Manufacturer Narrative

Initial medwatch submitted to the fda on 29/dec/2022.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 orbera365 system is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight loss maintenance.The orbera365 system is indicated for: temporary use for weight loss in overweight and obese patients (bmi 27-50) who failed to achieve and maintain weight loss with a supervised weight-control program.Pre-surgical temporary use for weight loss in obese and super obese patients (bmi 40 and above or a bmi of 35 with comorbidities) prior to obesity or other surgery, in order to reduce surgical risk.The maximum placement period for the orbera365 system is 12 months, and it must be removed at that time or earlier.The physiological response of the patient to the presence of the igb 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 adverse events.Each patient should be instructed regarding symptoms of deflation, gastrointestinal obstruction, acute pancreatitis, igb inflation after placement (i.E.Spontaneous hyperinflation), ulceration, gastric and esophageal perforation, and other adverse events which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Patients need to be evaluated and the device removed at or within 12 months of placement."complications: possible complications of the use of the orbera365¿ system include: gastric discomfort, feelings of nausea and vomiting following igb placement as the digestive system adjusts to the presence of the igb.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.Igb deflation (i.E.Collapse) 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 investigator determined that a device history record (dhr) review is required for this complaint, as the complaint is vigilance or mdr reportable and there was one other similar complaint ((b)(4)) against this lot number, af04760 and allegation.Dhr is in process for (b)(4).

Manufacturer Narrative

Supplement #x medwatch submitted to the fda on 30/jan/2023.Additional information: the investigator determined that a device history record (dhr) review is required for this complaint, as the complaint is reportable and there was one other similar complaint against this lot number af04760; and found the subject product met all specifications and requirements in effect at the time of manufacture.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 15/dec/2022.A deflated balloon with brown coloration on the shell was returned.Under microscopic analysis, the large hole on the shell has rounded edges and rolls inward.Due to the large hole, functional evaluation of the device could not be conducted.The complaint has been verified as it is uncertain how the large 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 large 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: adriana russell ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5128523757
• MDR Report Key: 16069837
• MDR Text Key: 308493053
• Report Number: 3006722112-2022-00126
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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,Followup
• Report Date: 11/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2023
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF04760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2021
• 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: 25 YR
• Patient Sex: Male
• Patient Weight: 100 KG