MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND® SYSTEM 9.75 WITH ACCESS PORT I; ADJUSTABLE GASTRIC BAND

Model Number	B-2210
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown taper.Medwatch sent to fda on 04/24/2017.Should the device be removed, a visual examination may determine the connecter type associated with the reported events.Device labeling addresses the reported event of "leak(s)" 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.When adjusting band volume, use of an inappropriate needle may cause access port leakage and require re-operation to replace the port.Use only lap-band ap system access port needles.Do not use standard hypodermic needles, as these may cause leaks.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.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 "defective band, location of where the port and the tubing meets has a hole in it".Physician confirmed, device remains implanted at this time, but will be removed and replaced.

• Brand Name: LAP-BAND® SYSTEM 9.75 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: 6516383
• Report Number: 3006722112-2017-00133
• Device Sequence Number: 1594646
• Product Code: LTI
• UDI-Device Identifier: 10811955020145
• UDI-Public: (01)10811955020145(11)050407(17)07Y04D0610)1091920
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2017

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: 04/06/2007
• Device Model Number: B-2210
• Device Catalogue Number: B-2210
• Device Lot Number: 1091920
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2017
• Initial Report FDA Received Date: 04/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 68