MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND SYSTEM; ADJUSTABLE GASTRIC BAND

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

Patient Problems Dysphagia/ Odynophagia (1815); Nerve Damage (1979); Regurgitation (2259)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

Unknown taper.This event was reported by the patient.To date, apollo has been unable to confirm the reported events with the patient's physician.A review of the labeling notes the following: adverse events: it is important to discuss all possible complications and adverse events with your patient.Complications which may result from the use of this product include the risks associated with the medications and methods utilized in the surgical procedure, the risks associated with any surgical procedure and the patient's degree of intolerance to any foreign object implanted in the body.Ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.Warnings: patients should be advised that the lap-band ap® system is a long-term implant.Explant and replacement surgery may be indicated at any time.Medical management of adverse reactions may include explantation.Revision surgery for explantation and replacement may also be indicated to achieve patient satisfaction.

Event Description

Reported as: a patient with the orbera intragastric balloon had experienced serious symptoms related to swallowing and regurgitation.Patient consulted with a bariatric specialist and was diagnosed with severe nerve damage to the esophagus as a result of the procedure.The device was removed.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital 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, ; CS
• Manufacturer Contact: laura lebouef ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 7830213
• MDR Text Key: 118714844
• Report Number: 3006722112-2018-00238
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 08/01/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/29/2018
• 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
• Patient Outcome(s): Required Intervention