MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) ORBERA INTRAGASTRIC BALLOON; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number B-50000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Vomiting (2144)

Event Date 08/26/2015

Event Type  malfunction  

Manufacturer Narrative

Medwatch sent to fda on: 09/25/2015.No additional information has been reported to allergan regarding the model number, serial number, the event date, implant date, explant date, diagnostic testing, patient data or further event details.The reporter of the complaint was asked to return the product for analysis.The device has not yet been received by allergan.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Device labeling addresses the reported event of vomit as follows: 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 results 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.Balloon replacement: caution: a larger initial fill volume in the replacement balloon may result in severe nausea, vomiting or ulcer formation.Device labeling addresses the reported event of pain as follows: possible complications of the use of the orbera system include: abdominal or back pain, either steady or cyclic.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.

Event Description

Healthcare professional reported "patient presented abdominal pain, intense sudden vomiting, and abdominal distention.Endoscopy showed that bib had hyper inflated.Product was removed and it has not been replaced.".

• Brand Name: ORBERA INTRAGASTRIC BALLOON
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capital of texas hwy; bulding 1, suite 300; austin, TX 78748 ; 8555513123
• MDR Report Key: 5105488
• MDR Text Key: 26805068
• Report Number: 3006722112-2015-00415
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 09/03/2015

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 Catalogue Number: B-50000
• Device Lot Number: 2690137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2015
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 79