MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND SYSTEM VG; ADJUSTABLE GASTRIC BAND

Model Number VG

Device Problem Leak/Splash (1354)

Patient Problems Failure of Implant (1924); Weight Changes (2607)

Event Date 05/08/2014

Event Type  Injury  

Manufacturer Narrative

Taper ii the product was returned for analysis, and visual examination confirmed this was a taper ii.Evaluation summary: device evaluation was performed, and the band tubing was observed to be broken/separated.A linear opening was noted on the access port tubing.A leak test was then performed on the access port tubing, which was found to be leaking.A fill inspection test was performed, and there was no resistance to flow or blockage noted.Microscopic analysis noted a smooth-edged opening on the access port tubing.The band tubing had a striated opening, consistent with a surgical end cut.Device labeling addresses the possible outcome of a leak as well as follows: adverse events: unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.Caution: 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 Description

Reported as: the patient was noted to have weight gain.The physician accessed the port and only found 4cc instead of 11cc in the patient's lap-band system.It was determined to be a device leak, and the lap-band system was explanted.

• Brand Name: LAP-BAND SYSTEM VG
• 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, costa rica ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5157203
• MDR Text Key: 28553586
• Report Number: 3006722112-2015-00459
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020206
• UDI-Public: 10811955020206
• 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,user faci
• Reporter Occupation: Physician
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/11/2008
• Device Model Number: VG
• Device Catalogue Number: B-2250
• Device Lot Number: 1259730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2006
• 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: 63 YR
• Patient Weight: 101