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

Model Number	B-2265
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Taper ii.Medwatch sent to the fda on 09/22/2016.The device was returned to apollo for analysis, and visual examination confirmed the connecter type as taper ii.Visual inspection noted brown particles on the port housing and on the port base.Yellow discoloration was observed on the port tubing and port base.Non-penetrating nicks were observed on the port housing and around the suturing holes.A port leak test was performed and no leakage was observed.A fill inspection test was performed and no blockage or resistance to flow was observed.Device labeling addresses the possible event of port leak as follows.Precautions: care must be taken to place the access port in a stable position away from areas that may be affected by significant weight loss, physical activity or subsequent surgery.Failure to do so may result in the inability to perform percutaneous band adjustments.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.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 or Problem Description
Reported as a patient with the lap-band system was reported to have a "port leak." the device was explanted.

• Brand Name: LAP-BAND AP LARGE WITH ACCESS PORT II
• 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: 5970218
• Report Number: 3006722112-2016-00282
• Device Sequence Number: 19007264
• Product Code: LTI
• UDI-Device Identifier: 10811955020237
• UDI-Public: 10811955020237
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2016

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: Health Professional
• Device Expiration Date: 01/20/2016
• Device Model Number: B-2265
• Device Catalogue Number: B-2265
• Device Lot Number: 2540388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2016
• Initial Report FDA Received Date: 09/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 94