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

Model Number B-4800

Device Problems Fluid/Blood Leak (1250); Expulsion (2933)

Patient Problem Failure of Implant (1924)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

The reporter confirmed the explanted device will not be return to apollo for analysis.Device labeling addresses the reported event as follows: precautions: a patient whose deflated balloon has moved into their intestines must be monitored closely for an appropriate period of time (at least 2 weeks) to confirm its uneventful passage through the intestine.Adverse events: it is important to discuss all possible complications and adverse events with your patient.Complications that may result from the use of this product include the risks associated with the medications and methods utilized in the endoscopic procedure, the risks associated with any endoscopic procedure, the risks associated with the orbera intragastric balloon specifically, and the risks associated with the patient's degree of intolerance to a foreign object placed in the stomach.Possible complications of the use of orbera¿ include: balloon deflation and subsequent replacement.Warnings: deflated devices should be removed promptly.Patients should be advised that balloon deflation may lead to serious adverse events including bowel obstruction and need for emergency surgery.Patients should immediately call their physician to receive instructions on preparing for removal of the balloon.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, gastric and esophageal perforation and other complications 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 6 months of placement.

Event Description

Reported as: a patient with the orbera intragastric balloon experienced spontaneous deflation of orbera.No balloon was there when physician went in to remove the 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: 7752307
• MDR Text Key: 116089599
• Report Number: 3006722112-2018-00206
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: 10811955020619
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2018

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: 10/03/2018
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Device Lot Number: AF00219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2016
• 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
• Treatment: ANDROGEL; ASPIRIN; FISH OIL; GLIMEPIRIDE; GLUCOSAMINE; JANUVIA; LOSARTAN; METFORMIN; MULTIVITAMIN; NIACIN; PANTOPRAZOLE; SIMVASTATIN
• Patient Age: 57 YR
• Patient Weight: 103