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

Catalog Number B-2240

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Achalasia (1692); Nausea (1970); Vomiting (2144); Regurgitation (2259)

Event Date 06/09/2014

Event Type  Injury  

Event Description

Healthcare professional reported band unfilled, "patient complained of vomiting, nighttime reflux, poor solid food tolerance, and frequent regurgitation".Patient continued to complain of "nausea and vomiting despite having a completely empty band".Diagnostic imaging showed "delayed passage of contrast with a narrow opening".The entire lap-band system was explanted.

Manufacturer Narrative

(b)(4).Taper ii.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 this report.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Vomiting, food intolerance, esophageal dysmotility, reflux and nausea are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.

Manufacturer Narrative

Visual examination of the returned device determined the access port tubing connector to be a taper ii.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)
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): APOLLO ENDOSURGERY; 1120 s capital of texas hwy
• Manufacturer Contact: laura leboeuf ; 1120 s capital of texas hwy; bldg 1, ste 300; austin, TX 78748 ; 8555513123
• MDR Report Key: 4814426
• MDR Text Key: 5834885
• Report Number: 3006722112-2015-00150
• Device Sequence Number: 1
• Product Code: LTI
• 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: Health Professional,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2010
• Device Catalogue Number: B-2240
• Device Lot Number: 1542724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2015
• Initial Date FDA Received: 06/01/2015
• Supplement Dates Manufacturer Received: 08/20/2015
• Supplement Dates FDA Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2008
• 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: PREVACID
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 122