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

Catalog Number B-20260

Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250); Inflation Problem (1310); Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 07/26/2013

Event Type  malfunction  

Event Description

Physician reported: six months ago, following implant, couldn't access band port, suspected port tilt, referred for x-ray.Following month, x-ray was performed which confirmed port tilt.Two months following x-ray, port re-sited in theatre (0.5mi saline added to band in theatre).Patient felt no restriction since port re-sited, due to excess swelling, physician was unable to perform adjustment.Following month, swelling had reduced with 1.5mls of saline added.Three weeks later, kink in tubing protruding in a triangular shape above the port incision site.Two weeks later, kink is still obvious but less prominent.One month later , blood stained saline with floating particles removed from band 203mls loss of fluid.Referred to x-ray.Later in the month, x-ray took place which reported visible leak.Physician scheduled further surgery.

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 model 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.The reporter of the event was asked to return the product for analysis.Allergan has not received the product at this time.Therefore, no analysis or testing has been done.No additional information has been reported to allergan regarding the serial number.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 reported event of displacement as follows: 'access ports have been reported to be "flipped" or inverted.If you initially see an oblique or side view on x-ray, then either reposition the patient or the x-ray equipment until you obtain a perpendicular, overhead (0 degree) view.Targeting the port for needle penetration can be difficult if this orientation is not controlled.Be aware that an upside down (180 degree) port shows the same image." device labeling addresses the reported event of difficulty adding/removing saline as follows: "it is important to remove any additional saline via the access port so no air will enter the lap-band system, compromising later adjustments.Device labeling addresses the reported event of visibility/palpability as follows: "precautions: 6, care must be taken to place the access port in a stable position away from areas that may be affected by significant weight loss, physical activity, or subsequent surgery.Failure to do so may result in the inability to perform percutaneous band adjustments.

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): COSTA RICA; 900 parkway global park; zona franca; la aurorade heredia ; CS
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117 ; 8059615405
• MDR Report Key: 3856989
• MDR Text Key: 4661945
• Report Number: 2024601-2014-00062
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B-20260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2014
• Initial Date FDA Received: 02/13/2014
• 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