MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA 365 INTRAGASTRIC BALLOON

Model Number B-50012

Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250); Migration or Expulsion of Device (1395); Unintended Deflation (4061)

Patient Problem Failure of Implant (1924)

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

Combined medwatch submitted to the fda on 10nov2023.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 migration "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 investigator determined that a device history record (dhr) review is required for this complaint due to the complaint being mdr reportable.The subject product met all specifications and requirements in effect at the time of manufacture.There were no other similar complaint against this lot number, af05505 and allegation.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.Lab analysis was not able to replicate the reported event of "deflation and migration", as the device was not returned.The user effects of "deflation and migration" is known and labeled possible adverse event.

Event Description

Healthcare professional reported patient was lacking stomach restriction.The balloon was determined to be absent during an examination.

• Brand Name: ORBERA 365 INTRAGASTRIC BALLOON
• Type of Device: INTRAGASTRIC BALLOON
• 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; bldg b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: adriana russell ; 1120 s. capital of texas hwy; bldg. 1 ste. 300; austin, TX 78746 ; 5122795114
• MDR Report Key: 18112850
• MDR Text Key: 328973510
• Report Number: 3006722112-2023-00221
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020725
• UDI-Public: (01)10811955020725(17)20250322(10)AF05505
• 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
• Report Date: 10/17/2023

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
• Device Operator: Health Professional
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF05505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2023
• 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: 30 YR
• Patient Sex: Female
• Patient Weight: 70 KG