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

Model Number B-50000

Device Problems Fluid/Blood Leak (1250); Defective Component (2292); Expulsion (2933); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

Medwatch sent to fda on 09/24/2018.The reporter confirmed the explanted device will not be return to apollo for analysis.Device labeling addresses the reported event as follows: warnings and precautions: the risk of balloon deflation and intestinal obstruction (and therefore possible death related to intestinal obstruction) is significantly higher when balloons are left in place longer than 6 months or used at larger volumes (greater than 700 cc).Deflated devices should be removed promptly.A patient whose deflated balloon has moved into the intestines must be monitored closely for an appropriate period of time to confirm its uneventful passage through the intestine.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.If it is necessary to replace a balloon which has spontaneously deflated, the recommended initial fill volume of the replacement balloon is the same as for the first balloon or the most recent volume of the removed balloon.A greater initial fill volume in the replacement balloon may result in severe nausea, vomiting or ulcer formation.Possible complications of the use of the orbera® system include: balloon deflation and subsequent replacement.Balloon placement and inflation: note: during the filling process the fill tube must remain slack.If the fill tube is under tension during the intubation process, the fill tube may dislodge from the balloon, preventing further balloon deployment.Warning: rapid fill rates will generate high pressure which can damage the orbera® system valve or cause premature detachment.The following filling recommendations are provided to avoid inadvertent valve damage or premature detachment: a balloon with a leaking valve must be removed immediately.A deflated balloon can result in a bowel obstruction, which can result in death.Bowel obstructions have occurred as a result of unrecognized or untreated balloon deflation.

Event Description

Reported as: during the placement of the orbera intragastric balloon, physician reported it was very hard to fill balloon with saline and not able to fill the balloon properly.Leakage was noted from valve during filling.Physician completed the surgery with only 400 cc of saline in the balloon.A week later during an endoscopic examination, the balloon was found to be missing in the stomach.Physician confirmed the balloon had migrated but there was no obstruction.Patient was replaced with a new balloon.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capitol 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, costa rica ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795100
• MDR Report Key: 7903061
• MDR Text Key: 121567674
• Report Number: 3006722112-2018-00246
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/27/2018

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 Expiration Date: 04/18/2020
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: AF01834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2018
• 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: 45 YR
• Patient Weight: 155