MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND AP SMALL WITH ACCESS PORT II SYSTEM; ADJUSTABLE GASTRIC BAND

Model Number B-20260

Device Problem Fluid/Blood Leak (1250)

Patient Problems Regurgitation (2259); Patient Problem/Medical Problem (2688)

Event Date 07/08/2013

Event Type  malfunction  

Manufacturer Narrative

Device labeling addresses the reported events as follows: precautions: care must be taken during band adjustment to avoid puncturing the tubing that connects the access port and band, as this will cause leakage and deflation of the inflatable section.Failure to create a stable, smooth path for the access port tubing, without sharp turns or bends, can result in tubing breaks and leakage.In order to avoid incorrect placement, the port should be placed lateral to the trocar opening.A pocket must be created for the port so that it is placed far enough from the trocar path to avoid abrupt kinking of the tubing.When adjusting band volume, use of an inappropriate needle may cause access port leakage and require reoperation to replace the port.Use only lap-band ap® system access port needles.Do not use standard hypodermic needles, as these may cause leaks.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.Deflation of the band may occur due to leakage from the band, the port or the connecting tubing.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: the patient with lap-band system had "reflux and band in a deflated state for the last 3 years.Now all weight lost returned and wanted to inflate the band." physician arranged for a radiological fill but the fill restriction was very short lasting.Later detected a leak in the tubing joint on the port side.Physician had the tubing trimmed and reconnected.Device remains implanted.

• Brand Name: LAP-BAND AP SMALL WITH ACCESS PORT II SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• 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 capital of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 6209281
• MDR Text Key: 63476480
• Report Number: 3006722112-2016-00404
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000008
• 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: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/23/2010
• Device Model Number: B-20260
• Device Catalogue Number: B-20260
• Device Lot Number: 1670283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2008
• 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 Age: 48 YR
• Patient Weight: 112