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

Device Problem Extrusion (2934)

Patient Problems Erosion (1750); Pyrosis/Heartburn (1883); Scarring (2061); No Code Available (3191)

Event Date 08/26/2012

Event Type  Injury  

Manufacturer Narrative

Unknown taper.Apollo received the maude event report (mw5042893) from fda on 08/12/2015.This report has no contact information for further follow-up, and therefore apollo is unable to request the product be returned, serial number, or clarification of events associated with this report.Device labeling addresses the event reported and 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.Adverse events: it is important to discuss all possible complications and adverse events with your patient.Complications which may result from the use of this product include the risks associated with the medications and methods utilized in the surgical procedure, the risks associated with any surgical procedure and the patient's degree of intolerance to any foreign object implanted in the body.Caution: patients should be advised that the lapband® system is a long-term implant.Explant and replacement surgery may be indicated at any time.Medical management of adverse reactions may include explantation.Revision surgery for explantation and replacement may also be indicated to achieve patient satisfaction.Caution: it is the responsibility of the surgeon to advise the patient of the known risks and complications associated with the surgical procedure and implant.

Event Description

Reported via maude event report (mw 5042893) as: "my lap-band eroded through my stomach.At the time it wasn't even filled and should not have been putting undo pressure on my stomach.I had to have emergency surgery.I now have permanent scarring and suffer reflux and delayed gastric emptying.In addition, after having the band for about 2 years i began having autoimmune issues.".

• 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: 5069196
• MDR Text Key: 25483643
• Report Number: 3006722112-2015-00349
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2015
• 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