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

Catalog Number B-2240

Device Problems Fluid/Blood Leak (1250); Device Slipped (1584)

Patient Problems Failure of Implant (1924); Not Applicable (3189)

Event Date 10/09/2011

Event Type  Injury  

Event Description

Physician reported recent lap-band port removal and replacement surgery due to a "leaking port.".

Manufacturer Narrative

Taper ii.The device has been received and is pending analysis.Following device analysis any additional information will be reported in a supplemental medwatch.Device labeling addresses the possible outcome of leakage as follows: "deflation of the band may occur due to leakage from the band, the port or the connector tubing.".

Manufacturer Narrative

Taper ii.Medwatch sent to fda on 11/10/2014.Visual examination of the returned device determined the access port tubing connector to be a taper ii.Device analysis of the access port and the taper tubing junction indicated a smooth opening consistent with wear and tear.Band tubing was broken with striations consistent with surgical end cut.Damaged port septum was missing material.Device labelling addresses the potential for smooth openings 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 possible outcome of leakage as follows "when adjusting band volume take care to ensure the radiographic screen is perpendicular to the needle shaft (the needle will appear as a dot on the screen).This will facilitate adjustment of needle position as needed while moving through the tissue to the port"."when adjusting band volume once the septum is punctured, do not tilt or rock the needle as this may cause fluid leakage or damage to the septum.".

Manufacturer Narrative

Device labeling addresses the possible outcome of band slippage as follows.Band slippage is a surgical/physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.

Event Description

Healthcare professional reported an event of band slippage / gastric prolapse, treatment not reported.

Event Description

Healthcare professional updated the event of band slippage/gastric prolapse to include the following treatment; hospitalization and surgery which consisted of a lap-band®ap system surgical revision to re-position the lap-band®ap system (with preservation of same band).Healthcare professional reported an event of gastroesophageal reflux; a lap-band®ap system adjustment took place to treat the event.

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): COSTA RICA; 900 pkwy global; park zona franca
• Manufacturer Contact: laura leboeuf ; 1120 s capital of texas hwy; bulding 1, suite 300; austin, TX 78748 ; 8555513123
• MDR Report Key: 4515810
• MDR Text Key: 18088287
• Report Number: 2024601-2014-00560
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020183
• UDI-Public: (01)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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/27/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2012
• Device Catalogue Number: B-2240
• Device Lot Number: 1800147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• 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): Hospitalization; Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 106 KG