MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND SYSTEM; ADJUSTABLE GASTRIC BAND

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

Patient Problems Erosion (1750); Paresis (1998); Perforation (2001)

Event Date 07/14/2015

Event Type  Injury  

Manufacturer Narrative

Unknown taper.Manufacturer received a copy of medwatch (b)(4) from the user facility on 08/06/2015.The product associated with this report will not be returned.User facility stated the device is available for on-site evaluation only, and the device will not be returned to the manufacturer.Device serial and catalog number were requested of the reporter, reporter stated they are unknown.Without catalog or serial number, taper type could not be determined.Device labeling addresses the possible outcome of erosion as follows: precautions: over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation.Anti-inflammatory agents, such as aspirin and nonsteroidal anti-inflammatory drugs (nsaids), may irritate the stomach and should be used with caution.The use of such medications may be associated with an increased risk of erosion.Insufficient weight loss may be caused by pouch enlargement or, more infrequently, band erosion in which case further inflation of the band would not be.Adverse events: there is a risk of band erosion into stomach tissue.Erosion of the band into stomach tissue has been associated with revision surgery after the use of gastric-irritating medications, after stomach damage and after extensive dissection or use of electrocautery, and during early experience.Symptoms of band erosion may include reduced weight loss, weight gain, access port infection, or abdominal pain.Reoperation to remove the device is required.Warning: any damage to the stomach during the procedure may result in erosion of the device into the gi tract.Caution: do not over-dissect the opening.Excessive dissection may result in movement or erosion of the band.

Event Description

First reported by user facility via fda mw (b)(4) as "lap-band was removed due to erosion of the band that resulted in a stomach leak.Developed gastroparesis post lap-band placement." follow-up with user facility confirmed the lap-band was removed due to erosion.Additional information found that "upon removal of the device a small perforation was noted, a repair was performed with no leak noted.".

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capitol of texas hwy; bldg 1, ste 300; austin TX 78746
• Manufacturer (Section G): ALLERGAN; global park free zone; 900 global park; la aurora de heredia, costa rica ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5055140
• MDR Text Key: 24980710
• Report Number: 3006722112-2015-00339
• 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: other,user facility
• Reporter Occupation: Physician
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2015
• 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: 57 YR
• Patient Weight: 114