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

Model Number B-50000

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erosion (1750); Dehydration (1807); Pain (1994); Vomiting (2144); Dizziness (2194); Malaise (2359); Obstruction/Occlusion (2422); Constipation (3274)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the device was returned to apollo, and a visual inspection was performed.The balloon was noted to be discolored, as the shell and center patch were dark green in appearance.A valve test was performed and the flow of fluid was continuous and unobstructed.An air leak test was not feasible as the device was noted to have a large tear.Under microscopic analysis the origination point of the tear was noted to be striated, consistent with device removal activities.Brown particles were noted to be in the inner surface of the valve channel.A review of device labeling noted the following: 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, acute pancreatitis, spontaneous inflation, 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.Possible complications: possible complications of the use of orbera include: adverse health consequences resulting from weight loss.Gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.Continuing nausea and vomiting.This could result from direct irritation of the lining of the stomach or as a result of the balloon blocking the outlet of the stomach.It is even theoretically possible that the balloon could prevent vomiting (not nausea or retching) by blocking the inlet to the stomach from the esophagus.Abdominal or back pain, either steady or cyclic.Bacterial growth in the fluid which fills the balloon.Rapid release of this fluid into the intestine could cause infection, fever, cramps and diarrhea.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.-spontaneous over inflation of an indwelling balloon with symptoms including intense abdominal pain, swelling of the abdomen (abdominal distension) with or without discomfort, difficulty breathing, and/or vomiting.Patients experiencing any of these symptoms should be counseled to seek immediate care.Note that continued nausea and vomiting could result from direct irritation of the lining of the stomach, as a result of the balloon blocking the outlet of the stomach, or hyperinflation of the balloon.

Event Description

Reported as: a patient with the orbera intragastric balloon had been "admitted via emergencies for sub-occlusive syndrome on distension of the gastric balloon.On (b)(6)2018 the patient received an intra-gastric balloon placement, in the context of obesity with bmi at 38.For 15 days, while the patient was on vacation abdominal pain and vomiting incoherent to each food intake.No stool since (b)(6); no gas for a few days.Dizziness and significant fatigue.The patient lost 8 kg in the last 2 weeks.It is presented to the emergency department on the (b)(6), where an abdominal ct scan is performed and highlights: intragastric balloon of 15.5 cm diameter containing a hydro-aeric level with a discrete gastric liquid stasis at its periphery without sign of digestive occlusion.(no esophageal distension).The presence of hydro-aerial levels within the balloon suggests a lack of tightness of it." further information notes: vomiting and abdominal pain as part of the sub-occlusive syndrome on gastric balloon distension.Intragastric balloon removal; erosive gastropathy.Acute renal failure pre-renal on vomiting for 2 weeks, resolved after hydration.

• Brand Name: ORBERA 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
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, ; CS
• Manufacturer Contact: tracy whisman ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 8912217
• MDR Text Key: 155714473
• Report Number: 3006722112-2019-00145
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 05/10/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: AF01462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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; Required Intervention
• Patient Age: 47 YR