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

Model Number B-50000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blood Loss (2597); Patient Problem/Medical Problem (2688)

Event Date 08/28/2017

Event Type  Injury  

Manufacturer Narrative

The reporter confirmed the explanted device will not be return to apollo for analysis.Further information has been requested from the reporter regarding patient outcome and medical history, however to date no additional information has been received by apollo.A review of the device labeling finds the following: contraindications: potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.Warnings and precautions: the physiological response of the patient to the presence of the orbera® 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.Possible complications of the use of the orbera® system include: injury to the digestive tract during placement of the balloon in an improper location such as in the esophagus or duodenum.This could cause bleeding or even perforation, which could require a surgical correction for control.Injury to the lining of the digestive tract as a result of direct contact with the balloon, grasping forceps, or as a result of increased acid production by the stomach.This could lead to ulcer formation with pain, bleeding or even perforation.Surgery could be necessary to correct this condition.Orbera® system placement and inflation: 1.Prepare the patient according to hospital protocol for gastroscopy.2.Perform gastroscopic inspection of esophagus and stomach.3.Remove gastroscope.4.Where there are no contraindications: a.Lubricate the orbera® system placement sheath with surgical lube-gel.B.Move the orbera® system gently down the esophagus and into the stomach.5.Reinsert the endoscope while the balloon is in situ to observe filling steps.The balloon must be below the lower esophageal sphincter and well within the stomach cavity.

Event Description

Reported as: a patient with the orbera intragastric balloon presented with bleeding from what seemed to be a deulafoy's similar lesion that was observed in the fundus.The bleeding was characterized as life-threatening.Device was removed.The patient had multiple transfusions and endoscopic treatment.The patient had "gastroskopi with heamostase to stop bleeding" and was admitted to the intensive care because of blood loss.The physician stated the event was not procedure related however the cause is unknown.

• 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: 7304415
• MDR Text Key: 101208323
• Report Number: 3006722112-2018-00080
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/15/2019
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: AF00756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2017
• 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 Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 38 YR