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

Model Number B-2240

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2017

Event Type  malfunction  

Manufacturer Narrative

Taper ii.Medwatch sent to fda on 07/03/2017.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." "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 lapband 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." "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 Description

Reported as: the patient had the entire lap-band system removed and replaced due to "ballooning of band by fluoroscopy.Unable to fill band.Removed and new device placed.".

Manufacturer Narrative

Device evaluation summary: a visual examination was performed on the received lap-band with access port i, taper ii.The band was separated from the port at the port tubing, approximately one inch from the port tubing ss connector.Scratches were noted on the port, port base and port holes.Needle marks were noted on the port septum.Brown and yellow particles were noted on the port and port base.The port septum was discolored, and was brown in appearance.The band ring and shell were noted to be discolored, and were light brown in appearance.Brown and white particles were noted on the inner surface of the shell.White particles were also noted on the outer surface of the shell.The band was separated in half, near the buckle.A fill inspection test was performed, and was unable to inject fluid through the port septum or port tubing.An air leak test was performed, and the air could not be injected into the band tubing to perform the air leak test due to a blockage in the band tubing.An unknown foreign material was noted on the end of the port tubing.The foreign material was clear and tacky.When the material was touched by tweezers it came out of the end of the port tubing.The end of the band and port tubing had striations, consistent with a surgical end cut.The lap-band ring and shell were noted to have striations, consistent with a surgical end cut to remove the device.

• Brand Name: LAP-BAND AP STANDARD W/ ACCESS PORT I
• 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
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795100
• MDR Report Key: 6684802
• MDR Text Key: 79032796
• Report Number: 3006722112-2017-00218
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020183
• UDI-Public: 10811955020183
• 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: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/24/2015
• Device Model Number: B-2240
• Device Catalogue Number: B-2240
• Device Lot Number: 2449133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2013
• 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: 41 YR
• Patient Weight: 95