MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND AP STANDARD WITH RAPIDPORT EZ; ADJUSTABLE GASTRIC BAND

Model Number AP STANDARD

Device Problem Leak/Splash (1354)

Patient Problem Weight Changes (2607)

Event Date 10/22/2015

Event Type  Injury  

Manufacturer Narrative

Unknown taper.Medwatch sent to fda on: 11/20/2015 the reporter of the event was asked to return the product for analysis, and to indicate the device serial and/or catalog number.The reporter stated the device would be returned, however they did not have serial or catalog information, but it may be included with the returned device.To date, the device has not been received by apollo, and without further device information the taper type is unknown.Visual inspection may determine the connecter type associated with this event.Device labeling addresses the possible outcome of leakage as follows: adverse events: 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 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: the patient had their initial lap-band system replaced one year ago for a slip.The patient was losing weight, but reported hearing a "pop" in the middle of the night and came in to have it checked.The port was checked and looked fine.The patient had reported loss of restriction following the pop, and the physician decided to replace the lap-band.During the replacement procedure saline was seen leaking by the buckle of the band.The physician reported that it appeared the band was leaking where the belt met the inner seam of the inflatable portion of the band.This report is for the replacement of the patient's second band.The initial lap-band system replaced due to a reported slip is captured in mw # 3006722112-2015-00527.

Manufacturer Narrative

Strain relief (rapidport ez).Supplement #1 - medwatch sent to fda on (b)(4) 2016.Device evaluation summary: the device was returned to apollo for analysis, and a visual inspection confirmed the connector type as rapidport ez.A visual inspection was performed on the device, and no irregularities were observed.A microscopic inspection was then performed, and noted an unidentified opening at the shell/belt junction.An air leak test was performed, and found leakage at the opening of the shell/belt junction.

• Brand Name: LAP-BAND AP STANDARD WITH RAPIDPORT EZ
• 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, costa rica, cs ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. capital of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5239904
• MDR Text Key: 31739153
• Report Number: 3006722112-2015-00530
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/12/2016
• Device Model Number: AP STANDARD
• Device Catalogue Number: B-2360
• Device Lot Number: 2557762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2014
• 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
• Patient Age: 47 YR
• Patient Weight: 101