MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND SYSTEM VG WITH ACCESS PORT I; ADJUSTABLE GASTRIC BAND

Model Number	B-2250
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/01/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown taper.This event was reported by the patient.To date, apollo has been unable to confirm the reported events with the patient's physician.Further information has been requested of the initial reporter regarding: when treatment or explant will be scheduled, physician information and if the device would be available to return for analysis.To date, no additional information has been received by apollo.Device labeling addresses the event as follows: precautions: care must be taken during band adjustment to avoid puncturing the tubing that connects the access port and band, as this will cause leakage and deflation of the inflatable section.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.Adverse event: ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.Deflation of the band may occur due to leakage from the band, the port or the connecting tubing.Warning: patients should be advised that the lap-band system is a long-term implant.Explant 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 "no restriction and began gaining weight.[patient] went in for 2 or 3 fills with no improvement.Diagnostic test showed there was a disconnected tubing near the band." revision surgery has not taken place at this time.

• Brand Name: LAP-BAND SYSTEM VG WITH ACCESS PORT I
• 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: 5856989
• Report Number: 3006722112-2016-00231
• Device Sequence Number: 10870420
• Product Code: LTI
• UDI-Device Identifier: 10811955020206
• UDI-Public: 10811955020206
• Combination Product (Y/N): N
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 07/11/2016

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: 01/09/2008
• Device Model Number: B-2250
• Device Catalogue Number: B-2250
• Device Lot Number: 1187527
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2016
• Initial Report FDA Received Date: 08/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 156