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

Device Problems Leak/Splash (1354); Material Integrity Problem (2978)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/29/2015

Event Type  malfunction  

Manufacturer Narrative

Unknown taper.The reporter of the event was asked to return the product for analysis, and to indicate product serial number.The reporter indicated the device would be returned, but that serial number was unknown.To date apollo has not received the device.If returned, visual examination may determine the connecter type associated with this event.The reporter of the event was asked to provide further information regarding the implant date, diagnostic testing, and patient information.The reporter stated they are unknown.Device labeling addresses the reported event of tubing break and leak as follows: adverse events: unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.Precautions: 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.Care must be taken to avoid damaging the band, its inflatable section or tubing, the access port or the calibration tube.Use only rubber-shod clamps to clamp tubing.Failure to use the tubing end plug during placement of the band may result in damage to the band tubing during band placement.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's lap-band system was reported to have "tubing perished and worn." the port was removed and replaced.

Manufacturer Narrative

Supplement #1 - medwatch sent to fda on 04/12/2016.Device evaluation summary: the device was returned for analysis, and visual examination confirmed the connector type as taper ii.A visual inspection was performed on the returned device, and noted white particles on the port septum.Non-penetrating scratches were noted on the port housing.The port base was also noted to be discolored, and brownish in color.An air leak test was performed and noted the device to be leaking from the port taper tubing.A fill inspection test was performed, and found no blockage or resistance to flow.A microscopic analysis was then performed, and observed a smooth opening on the port taper tubing.

• Brand Name: LAP-BAND 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, 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: 5364736
• MDR Text Key: 35920946
• Report Number: 3006722112-2016-00014
• 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: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 54 YR
• Patient Weight: 91