MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND SYSTEM 10.0CM; ADJUSTABLE GASTRIC BAND

Model Number	10.0CM
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/25/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Taper ii.Medwatch sent to fda on 02/04/2016.Device evaluation summary: the device was returned for analysis, and only the port tubing was received.Visual inspection was performed, and noted the tubing appeared discolored.Visual inspection also noted a tear on the tubing approximately 6 cm from the taper junction, as well as a second tear on the end which would connect to the ss connector.Leak testing was performed and observed leakage of the device, and confirmed the reported failure.Device labeling addresses the reported event 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.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 or Problem Description
Reported as: the physician noted that the patient's lap-band system was "missing saline from previous adjustments." the physician reported the lap-band system had "leakage of [the] band tubing 6 cm from [the] access port." the port was removed and replaced.

• Brand Name: LAP-BAND SYSTEM 10.0CM
• Common Device Name: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capitol of texas hwy; bldg 1, ste 300; austin TX 78746
• MDR Report Key: 5411893
• Report Number: 3006722112-2016-00049
• Device Sequence Number: 740080
• Product Code: LTI
• UDI-Device Identifier: 10811955020169
• UDI-Public: 10811955020169
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Report Date (Section B): 01/06/2016

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
• Operator of Device: Physician
• Device Expiration Date: 01/12/2007
• Device Model Number: 10.0CM
• Device Catalogue Number: B-2220
• Device Lot Number: 1066637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 78