MAUDE Adverse Event Report: APOLLO ENDOSURGERY LAP-BAND SYSTEM; ADJUSTABLE GASTRIC BAND

Device Problem Material Deformation (2976)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/10/2016

Event Type  malfunction  

Manufacturer Narrative

Unknown taper.The reporter of the event was asked to return the product for analysis once explanted, and to indicate product serial number.To date, neither the device nor any further device information has been received by apollo.Without device or device serial, the taper type is unknown.If returned, visual examination may determine the connector type associated with this event.Device labeling addresses the reported event as follows: precautions: care must be taken to avoid damaging the band, its inflatable section or tubing, the access port or the calibration tube.Use only rubber-shod clamps to clamp tubing.When adjusting band volume after the septum is punctured, do not tilt or rock the needle, as this may cause fluid leakage or damage to the septum.If fluid has been added, it is important to establish that the stoma is not too small before discharge.Care must be taken to not add too much saline, thereby closing the stoma.Check the adjustment by having the patient drink water.If the patient is unable to swallow, remove some fluid from the port, then re-check.A physician familiar with the adjustment procedure must be available for several days post-adjustment to deflate the band in case of an obstruction.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.Special notice: 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: a patient with the lap-band system was reported to have "the band is bulging out and can no longer be adjusted.Within the lumen of the gastric band device, there is an area that bulges when contrast is injected.This area is opposite the tubing insertion site." the device remains implanted.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. captial tx hwy; bldg. 1 suite 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
• MDR Report Key: 6464358
• MDR Text Key: 71914166
• Report Number: 3006722112-2017-00103
• Device Sequence Number: 1
• Product Code: LTI
• 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: Health Professional
• Type of Report: Initial
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 30 YR
• Patient Weight: 97