MAUDE Adverse Event Report: ALLERGAN LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

Catalog Number B-2260

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Obstruction/Occlusion (2422)

Event Date 11/20/2014

Event Type  Injury  

Event Description

Healthcare professional reported that two days after implant, patient admitted to hospital with an inability to tolerate fluids and an obstruction.Original device removed and replaced with a larger size.

Manufacturer Narrative

(b)(4).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 model number, 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 this report.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Intolerance and obstruction are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.

Manufacturer Narrative

Analysis noted that the band tubing was broken with striations consistent with surgical end cut to remove the device.

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer Contact: krista alvarado ; 301 w. howard lane suite 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 4469184
• MDR Text Key: 5185258
• Report Number: 2024601-2015-00017
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020220
• UDI-Public: (01)10811955020220
• 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
• Type of Report: Initial
• Report Date: 01/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2016
• Device Catalogue Number: B-2260
• Device Lot Number: 2609823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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: 48 YR
• Patient Weight: 133