MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL); IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number B-20260

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Slipped (1584)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/27/2015

Event Type  Injury  

Manufacturer Narrative

Taper ii.Medwatch sent to fda on: 08/11/2015.The reporter of the complaint was asked to return the product for analysis.The device has not yet been received by allergan.Based upon the serial number and implant date provided by the reporter the connector type is assumed to be a taper ii.Visual examination may determine the connector type associated with the report.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Band slippage, band restriction issues and fluid intolerance are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.

Event Description

Physician reported treating patient for band slip identified with a barium swallow.After treatment, patient could not tolerate fluids and physician reported "band too tight after repositioning." complaint device was explanted and replaced with a larger device.

Manufacturer Narrative

(b)(4).The access port connector associated with this report was not returned with the lap-band system by the reporter.Analysis noted a striated opening in the band tubing consistent with surgical removal of the device.

Event Description

Physician reported treating patient for band slip identified with a barium swallow.After treatment, patient could not tolerate fluids and physician reported "band too tight after repositioning." device was explanted and replaced with a larger device.

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capital of texas hwy; bulding 1, suite 300; austin, TX 78748 ; 8555513123
• MDR Report Key: 5003139
• MDR Text Key: 23116258
• Report Number: 3006722112-2015-00250
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020381
• UDI-Public: (01)10811955020381
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2013
• Device Catalogue Number: B-20260
• Device Lot Number: 2185136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 73