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

Model Number B-50012

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Apollo has not received the product at this time.Therefore no analysis or testing has been done.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 event of "deflation" as follows: warnings and precautions: the risk of balloon deflation and intestinal obstruction (and therefore possible death related to intestinal obstruction) may be higher when balloons are left in place longer than 12 months or used at larger volumes (greater than 700 cc).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, acute pancreatitis, spontaneous inflation, 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: balloon deflation and subsequent replacement.

Event Description

Reported complaint: "patient 2 - retrieval - orbera365 retrieved at month 12 - when implanted it was inflated 600cc, once removed balloon had several cc less.Again the doctor says [they are] sure there has been a leakage.".

Manufacturer Narrative

The device was returned to the apollo device analysis laboratory on 07/nov/2019.Analysis of the device is ongoing.

Manufacturer Narrative

Supplement #2.Additional information: h3, h6, h10.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 07/nov/2019.A discolored deflated balloon was returned for evaluation.The fill tube and fill kit were not returned.As the device was not received with the fill tube, a sample fill tube was used for device testing and no blockage was observed and the flow of di water was continuous and unobstructed.An air leak test could not be conducted due to multiple holes on the shell.Under microscopic analysis, the holes on the shell have striated edges which are consistent with an instrument tool for removing the balloon.There were no holes observed on the shell or at the valve that could have caused leakage prior to the removal process.

• Brand Name: ORBERA365 INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 9476739
• MDR Text Key: 183691472
• Report Number: 3006722112-2019-00174
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1