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 Ischemia (1942); Nausea (1970); Pain (1994); Vomiting (2144); Injury (2348)

Event Date 05/25/2017

Event Type  Injury  

Manufacturer Narrative

The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Review of the device labeling notes 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 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: 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.

Event Description

Reported event from journal article titled: "ischemic renal injury complicating intragastric balloon insertion", acg case reports journal reported an orbera patient experienced ischemic renal injury as a complication of intragastric balloon (igb) insertion for weight reduction.Patient had no immediate post-procedure complications except for few episodes of nausea and vomiting.On day 40 post-igb insertion, patient presented to the emergency department with a 2-day history of left-flank pain associated with nausea but no vomiting.Abdominal (computed tomography) ct with intravenous contrast showed a fully distended igb that directly compressed the left renal vein.The left kidney was enlarged (11.73 cm), with a wedge-shaped hypodense area in the renal cortex and peri-renal fat stranding.The patient underwent urgent upper endoscopy for igb removal.The gastric mucosa was intact and healthy.The patient responded well to treatment, with complete clinical and radiologic resolution after balloon removal.Urine cultures came back negative.Magnetic resonance imaging (mri) of the abdomen was done one week after balloon removal for interval follow-up.A previously noted left renal hypodense lesion resolved with no focal areas of decreased enhancement.Patient did not have an apparent cause of renal ischemia other than a significant compression of the renal vessels by the balloon as seen on imaging.

• 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): ALLERGAN; global park free zone; 900 global park; la aurora de heredia
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795100
• MDR Report Key: 7718706
• MDR Text Key: 114984686
• Report Number: 3006722112-2018-00179
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2018

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: Health Professional
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ONDANSETRON
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 25 YR
• Patient Weight: 93