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	Patient Problem/Medical Problem (2688)
Date of Event	09/28/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Taper ii.Further information has been requested of the initial reporter regarding the implant device information.To date, no additional information has been received by apollo.Device evaluation summary: the device was returned for analysis, and visual examination confirmed the connector type as taper ii.Visual inspection noted the port tubing/ss connector junction was discolored, and was observed to be yellow in color.Scratches/non-penetrating nicks were noted on the port septum and port holes.An air leak test was performed, and no leakage was noted.A microscopic analysis was performed, and noted that between the port septum and port housing, there was pulled material consistent with needle punctures.A fill test was performed, and no blockage or resistance to flow was noted.The band tubing was observed to have a surgical end cut, consistent with removal of the device.Device labeling addresses the reported event of a 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.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.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.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 "wasn't getting restriction, came for volume check [the patient] was supposed to have 8cc but only had 4cc." the port was removed and replaced.

• Brand Name: LAP-BAND AP LARGE 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: 5619536
• Report Number: 3006722112-2016-00106
• Device Sequence Number: 10890413
• Product Code: LTI
• UDI-Device Identifier: 10811955020237
• UDI-Public: 10811955020237
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2016

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 Model Number: B-2265
• Device Catalogue Number: B-2265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2016
• Initial Report FDA Received Date: 04/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 119