MAUDE Adverse Event Report: ALLERGAN LAP-BAND AP ADJUSTABLE GASTRIC BANDLING SYSTEM (LARGE)

Catalog Number B-20265

Device Problems Inflation Problem (1310); Migration or Expulsion of Device (1395); Material Twisted/Bent (2981)

Patient Problem Failure of Implant (1924)

Event Date 06/27/2013

Event Type  malfunction  

Event Description

Healthcare professional reported, pt requires revision due to initially having difficulty accessing port ten months prior.Required ultrasounds with adjustments.By last month, doctor noted port had possibly rotated 90 degrees and now unable to access.Surgery is scheduled within a few weeks.Follow-up findings: no failure of the port, the "tubing had twisted and tilted the port on an angle".The port was removed, and sutured in another position.Tubing was also repositioned but not shortened.Port confirmed to be an apii, taper ii access port released with band.The device remains implanted and will not be returned.

Manufacturer Narrative

The reporter of the complaint was asked to return the product for analysis if it is explanted in the future.The device was repositioned and remains implanted.Based upon the model number, serial number, implant date an identification provided by the reporter the connector type is assumed to be a taper ii.Visual examination may determine the connector type associated with this report.The reporter of the event was asked to return the product for analysis, if it is explanted in the future.It was repositioned during the procedure and allergan has not received the product at this time.Therefore no analysis or testing has been done.Device labeling addresses the reported event of difficulty adding/removing saline as follows: "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 and 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".Device labeling addresses the reported event of displacement as follows: "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".

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDLING SYSTEM (LARGE)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): COSTA RICA; 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117 ; 8059615867
• MDR Report Key: 3866817
• MDR Text Key: 20102549
• Report Number: 2024601-2014-00217
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2013
• Device Catalogue Number: B-20265
• Device Lot Number: 2075704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2011
• 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
• Treatment: SERETIDE INHALER DAILY
• Patient Age: 41 YR
• Patient Weight: 142