MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND AP SMALL SYSTEM WITH RAPIDPORT EZ; ADJUSTABLE GASTRIC BAND

Model Number C-20360

Device Problems Fluid/Blood Leak (1250); Device Issue (2379)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Date 03/22/2016

Event Type  malfunction  

Manufacturer Narrative

Strain relief.Medwatch sent to the fda on 08/30/2016.Further information has been requested of the initial reporter regarding: clarity as to why the port was replaced, device information, and patient 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 a strain relief.Red particles were observed on the port housing and strain relief connection junction.Yellow particles were observed between the strain relief assembly junction and the access port tubing.Fluid was observed inside the port.The anchors were observed to be partially deployed.A port leak test was performed and no leakage was observed.A fill test was performed and no blockage or resistance to flow was noted.The band tubing was broken with striations consistent with surgical end cut for removal of the device.Based on the information provided thus far, a review of device labeling reveals: 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.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.The manufacturer of the lap-band ap adjustable gastric banding system has designed, tested and manufactured it to be reasonably fit for its intended use.However, the lap-band ap system is not a lifetime product and it may break or fail, in whole or in part, at any time after implantation and notwithstanding the absence of any defect.Causes of partial or complete failure include, without limitation, expected or unexpected bodily reactions to the presence and position of the implanted device, rare or atypical medical complications, component failure and normal wear and tear.In addition, the lap-band ap system may be easily damaged by improper handling or use.

Event Description

Reported as: the patient's lap-band system was reported to have a "port replacement." the port was removed and replaced.

Manufacturer Narrative

Strain relief.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 events: deflation of the band may occur due to leakage from the band, the port or the connecting tubing.

Event Description

Additional information noted: "4 ml in band, should have been 5.7 ml.Patient found it easier to eat larger meals.".

• Brand Name: LAP-BAND AP SMALL SYSTEM WITH RAPIDPORT EZ
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capitol 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, ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. captial tx hwy; bldg. 1 suite 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5915883
• MDR Text Key: 53551915
• Report Number: 3006722112-2016-00283
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2017
• Device Model Number: C-20360
• Device Catalogue Number: C-20360
• Device Lot Number: 2699270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2016
• Initial Date FDA Received: 08/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2015
• 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 Age: 32 YR
• Patient Weight: 90