MAUDE Adverse Event Report: APOLLO ENDOSURGERY LAP-BAND AP STANDARD W/ ACCESS PORT II; ADJUSTABLE GASTRIC BAND

Model Number	B-2260
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Regurgitation (2259); Obstruction/Occlusion (2422)
Date of Event	08/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Taper ii.Device evaluation summary: the device was returned to apollo for analysis, and visual examination confirmed the connector type as taper ii.Needle marks were observed on the port septum.Red and brown particles were observed on the belt and inner surface of the band shell.A port leak test was performed and no leakage was observed.A fill inspection test was performed and no blockage was observed.Under microscopic analysis, both ends of the band tubing were noted to be striated, which is consistent with device removal activities.Device labeling addresses the reported events 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 events: it is important to discuss all possible complications and adverse events with your patient.Complications which may result from the use of this product include the risks associated with the medications and methods utilized in the surgical procedure, the risks associated with any surgical procedure and the patient's degree of intolerance to any foreign object implanted in the body.Ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.Unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.Obstruction of stomas has been reported as both an early and a late complication of this procedure.This can be caused by edema, food, improper initial calibration, band slippage, pouch torsion or patient non-compliance regarding choice and chewing of food.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: a patient with the lap-band system was reported to have a leak."[patient was] seen for evaluation of lapband intolerance.[patient] had the band placed for several years ago and lost almost (b)(6).[patient] has had numerous adjustments can either eat too much or is obstructed w/ gerd and dysphagia to solids.Leak found in operation." device was removed.

• Brand Name: LAP-BAND AP STANDARD W/ ACCESS PORT II
• Common Device Name: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. captial tx hwy; bldg. 1 suite 300; austin TX 78746
• MDR Report Key: 6981377
• Report Number: 3006722112-2017-00352
• Device Sequence Number: 13752346
• 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: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/24/2010
• Device Model Number: B-2260
• Device Catalogue Number: B-2260
• Device Lot Number: 1670830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Weight: 161