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

Catalog Number B-2240

Device Problem Device Slipped (1584)

Patient Problem Prolapse (2475)

Event Date 05/22/2015

Event Type  Injury  

Event Description

Healthcare professional reported a lap-band system "prolapse".No info was provided on when the problem was first noticed.The lap-band system was removed, but no info was provided on if it was replaced.

Manufacturer Narrative

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 implant date and explant 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.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.No additional info has been reported to allergan regarding the catalog number, serial number diagnostic testing, pt data or further event details.Device labeling addresses the reported events of band slippage as follows: require reoperation".

Manufacturer Narrative

Allergan has received the product however the analysis has not been completed at this time.

Event Description

Healthcare professional reported a lap-band system "prolapse." no information was provided on when the problem was first noticed.The lap-band system was removed, but no information was provided on if it was replaced.

Manufacturer Narrative

Taper ii.Visual examination of the returned device determined the access port tubing connector to be a taper ii.Analysis noted signs of erosion, discoloration, and acid degradation.Analysis noted the ring of the shell/band, buckle, belt and band tubing were broken with striations consistent with surgical end cuts for the removal of the device.Analysis noted a break with leakage in the shell.

Event Description

Healthcare professional reported a lap-band tm system "prolapse." no information was provided on when the problem was first noticed.The lap-band tm system was removed, but no information was provided on if it was replaced.

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
• 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: 4944946
• MDR Text Key: 6633325
• Report Number: 3006722112-2015-00219
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2015

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 Catalogue Number: B-2240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 54 YR