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

Model Number B-20260

Device Problem Fluid/Blood Leak (1250)

Patient Problem Failure of Implant (1924)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

Unknown taper.Medwatch sent to fda on 12/18/2018.The reporter of the event was asked to indicate product serial number.To date, no further device information has been received by apollo.The taper type is unknown.If returned, visual examination may confirm or determine another taper type associated with this event.Device labeling addresses the reported event as follows: precautions: it is the responsibility of the surgeon to advise the patient of the known risks and complications associated with the surgical procedure and implant.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 after the septum is punctured, do not tilt or rock the needle, as this may cause fluid leakage or damage to the septum.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.Unplanned 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 (removal) 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 lap-band system had the port removed and replaced due to no fluid could be injected or removed, volume discrepancy from previous fills.

• Brand Name: LAP-BAND AP SMALL W/ ACCESS PORT II
• Type of Device: ADJUSTABLE GASTRIC BAND ACCESS PORT
• 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: 8175564
• MDR Text Key: 131800097
• Report Number: 3006722112-2018-00323
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2011
• Device Model Number: B-20260
• Device Catalogue Number: B-20260
• Device Lot Number: 1778857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2009
• 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: 50 YR
• Patient Weight: 108