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

Model Number	B-2260
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/01/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Taper ii : device evaluation summary: the device was returned for analysis, and visual examination confirmed the connector type as taper ii.Visual inspection noted the returned port was observed to have yellow particles on the outer surface of the device.A suture was observed to be attached to one of the port holes.One of the port holes was damaged/broken, and the other two were observed to have rough edges.The port septum/port base was noted to have pulled material and scratches.A fill inspection was performed, and no blockage or resistance to flow was noted.The port taper tubing was observed to have a surgical end cut, consistent with the removal of the device.Device labeling addresses the reported event of port 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.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 patient's lap-band system was reported to have "come in for a fill, then came back for decreased satiety and no restriction.Patient had a volume check, and lost volume so they were sent for a upper gi." the port was removed and replaced.

• Brand Name: LAP-BAND AP STANDARD WITH ACCESS PORT II
• Common Device Name: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. captial of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 5591816
• Report Number: 3006722112-2016-00089
• Device Sequence Number: 278885
• Product Code: LTI
• UDI-Device Identifier: 10811955020220
• UDI-Public: 10811955020220
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2016

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: 04/18/2009
• Device Model Number: B-2260
• Device Catalogue Number: B-2260
• Device Lot Number: 1437948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2016
• Initial Report FDA Received Date: 04/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 77