MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAGB SYSTEM 10CM; ADJUSTABLE GASTRIC BAND

Model Number B-20220

Device Problem Fluid/Blood Leak (1250)

Patient Problems Adhesion(s) (1695); Weight Changes (2607)

Event Type  malfunction  

Manufacturer Narrative

Unknown taper.Medwatch sent to fda 02/23/2017.The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.If returned, visual examination may confirm or determine another taper type associated with this event.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.The tubing path should point in the direction of the access port connector so that the tubing will form a straight line with a gentle arching transition into the abdomen.When adjusting band volume, the needle must be inserted perpendicular to the access port septum.Failure to do so may cause damage to the port and result in 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.Gastric banding done as a revision procedure has a greater risk of complications.Prior abdominal surgery is commonly associated with adhesions involving the stomach.In the us pivotal study of severely obese adults, 42% of the subjects undergoing revision surgery were reported to have adhesions involving the stomach.Care and time must be taken to adequately release the adhesions to provide access, exposure and mobilization of the stomach for a revision procedure.Unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.

Event Description

Reported as: a patient had the entire lap-band system removed on (b)(6) 2016 due to "kink in the tubing." explanting physician had noted, "band was not holding fills, there was no fluid within the band, indicating fluid was leaking from the band itself." patient also had "recent weight gain".The lap-band system was originally implanted on (b)(6) 2006.The patient had a port revision and replacement surgery on (b)(6) 2012 due to "break in the tubing at the level where the tubing was coming into the abdominal wall, the tube was cracked completely and there was an obvious leak".Per op report, during the surgery on (b)(6) 2012, the explanting physician noted "removing the scar tissue".

• Brand Name: LAGB SYSTEM 10CM
• 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: 6355168
• MDR Text Key: 68225257
• Report Number: 3006722112-2017-00051
• 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
• Type of Report: Initial
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: B-20220
• Device Catalogue Number: B-20220
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/23/2017
• 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: AMBIEN; BUPROPION HCI XL; DICLOFENAC ER; ESCITALOPRAM; LEXAPRO; LOVASTATIN; LOVOTHYROXINE; VOLTAREN; WELLBUTRIN; ZOLPIDEM
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 64