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

Catalog Number AB-20260

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2015

Event Type  malfunction  

Manufacturer Narrative

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 catalog 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.Adhesion 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 information has been reported to allergan regarding the serial number, explant date, diagnostic testing, patient data or further event details.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." device labeling addresses the possible outcome of adhesions as follows: "gastric banding done as a revision procedure has a greater risk of complications.Prior abdominal surgery is commonly associated with adhesions involving the stomach.In the u.S.Study, 42% of the u.S.Patients undergoing revisions were reported to have developed adhesions involving the stomach.".

Event Description

Healthcare professional reported "break in tubing noticed on day of revision", "port cut off as tissue was hard to remove".The port was removed and replaced.

• 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; 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: 5043323
• MDR Text Key: 25255934
• Report Number: 3006722112-2015-00268
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/05/2015

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AB-20260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 56 YR
• Patient Weight: 127