MAUDE Adverse Event Report: ALLERGAN LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

Catalog Number LAP-BAND ADJUSTABLE GASTRIC BA

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Abdominal Pain (1685); Erosion (1750); Fistula (1862)

Event Date 07/01/2008

Event Type  Injury  

Event Description

Reported events of band migration, band erosion, "gastrocolic fistula formation", and abdominal pain within one patient from journal article; "simultaneous gastric and colic laparoscopic adjustable gastric band migration.Complication of bariatric surgery", obes surg (2010) (b)(4).Although the mfr of the device is unknown, it is allergan's approach to compliance to resolve all doubt in favor of reporting.

Manufacturer Narrative

The reporter of the complaint was asked to return the product for analysis as well as indicate the product serial number, date of event, implant date and explant date.Since allergan has not yet received this information the connector type cannot be identified nor an assumption made as to the type of connector associated with this complaint.Visual examination may determine the connector type.Allergan has not received the product at this time.Therefore, no analysis or testing has been done.Multiple requests for further information have been made.Allergan has received no response from the authors.Erosion, displacement, fistula, and pain are surgical, physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling addresses the reported event of erosion as follows: caution: "the band should not be sutured to the stomach.Suturing the band directly to the stomach may result in erosion." caution: "as with other gastroplasty surgeries, particular care must be taken during dissection and during implantation of the device to avoid damage to the gastrointestinal tract.Any damage to the stomach during the procedure may result in erosion of the device into the gi tract." caution: "over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation." caution: "anti-inflammatory agents, which may irritate the stomach, such as aspirin and non-steroidal anti-inflammatory drugs, should be used with caution.The use of such medications may be associated with the increase risk of erosion." device labeling addresses the reported event of displacement as follows: warning: "failure to secure the band properly may result in its subsequent displacement and necessitate re-operation." caution: "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." device labeling addresses the reported event of abdominal pain as follows: "there were additional occurrences of these events that were considered to be non-serious.Other adverse events considered related to the lap-band system that occurred in fewer than 1% of subjects included: abdominal pain, chest pain, incision pain and port site pain.".

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
• Manufacturer (Section D): ALLERGAN; goleta CA
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117 ; 8059615405
• MDR Report Key: 3659389
• MDR Text Key: 20702399
• Report Number: 2024601-2014-00068
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2014

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: LAP-BAND ADJUSTABLE GASTRIC BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2014
• Initial Date FDA Received: 02/18/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR