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

Model Number AP STANDARD

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395)

Patient Problem Weight Changes (2607)

Event Date 01/31/2013

Event Type  malfunction  

Manufacturer Narrative

Unknown taper.Medwatch sent to fda on: 10/15/2015.The device associated with this report has not been explanted, and thus is not available for evaluation.Further information regarding the serial number of the device was requested of the patient's physician, no additional information has been received to date.The product associated with this report remains implanted.To date, no intervention has been performed.Device labeling addresses the reported complaint as follows: brief description of procedure: the tubing is connected to the access port placed on the rectus muscle or fixed in an accessible subcutaneous space.The access port is then sutured in place utilizing the suture holes in the port base.Caution: care must be taken to place the access port in a stable position away from areas that may be affected by significant weight loss, physical activity, or subsequent surgery.Failure to do so may result in the inability to perform percutaneous band adjustments.Care must be taken during band adjustment to avoid puncturing the tubing which connects the access port and band, as this will cause leakage and deflation of the inflatable section.Adverse events: unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.Device has not been explanted.

Event Description

The patient reported that two years after implant of the lap-band system they had a port replacement.The patient went in for their first fill after the port replacement and were told by their physician the lap-band was not holding fluid and that they have an inoperative lap-band.The patient also reported they are gaining weight.The patient had an x-ray, and the physician could not access the port and believes the port turned over.This report is for the current band leak and port that is turned over.The port replacement that occurred two years after implant is documented in mdr 3006722112-2015-00446.

• Brand Name: LAP-BAND AP STANDARD
• 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: 5154873
• MDR Text Key: 28440888
• Report Number: 3006722112-2015-00445
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: AP STANDARD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2015
• 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: 58 YR
• Patient Weight: 125