MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND AP STANDARD W/RAPIDPORT EZ; ADJUSTABLE GASTRIC BAND

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

Strain relief (rapidport ez).Medwatch sent to fda on 03/10/2016.The device was returned to apollo for analysis.A visual analysis was performed on the returned lap-band and noted the device was discolored, and it appeared blue in color.Particles were noted on the inner surface of the band.An air leak test was performed and noted leakage at the junction of the buckle and shell.A microscopic analysis was then performed on the device, and noted an unidentified opening between the shell and the buckle.Device labeling addresses possible outcomes of band restriction issues and leak(s) as follows: 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.

Event Description

Reported as: a patient with the lap-band system was reported to have come "in due to no restriction.The reporter was unsure if any diagnostics tests were done prior to surgery.Surgery was done to evaluate if patient needed a revision.It was discovered that the lap-band was leaking (a hole) either between the buckle and the ring or the belt and the inner shell.The lap-band system was replaced.

Manufacturer Narrative

• Brand Name: LAP-BAND AP STANDARD W/RAPIDPORT EZ
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. captial of texas hwy; bldg 1, ste. 300; austin TX 78746
• Manufacturer (Section G): ALLERGAN; global park free zone; 900 global park; la aurora de heredia, costa rica, cs ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. capital of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5493698
• MDR Text Key: 40121358
• Report Number: 3006722112-2016-00061
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020268
• UDI-Public: 10811955020268
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2016
• Device Model Number: N/A
• Device Catalogue Number: B-2360
• Device Lot Number: 2688174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR