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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Feeding Problem (1850)

Event Date 05/06/2015

Event Type  Injury  

Manufacturer Narrative

Unknown taper.Medwatch sent to fda on 02/05/2016.The reporter of the event was asked to return the product for analysis, and to indicate device serial number.To date, apollo has not received the device nor additional device information.Without the device or device serial number, the connecter type cannot be determined.If returned, visual examination may determine the taper type associated with this event.This event was reported by a family member and the patient.To date, apollo has been unable to confirm the events with the patient's physician.Additional information regarding the description of events, device information, and patient information have been requested of the initial reporter.To date no further information has been received by apollo.Device labeling addresses the reported events as follows: adverse events: obstruction of stomas has been reported as both an early and a late complication of this procedure.This can be caused by edema, food, improper initial calibration, band slippage, pouch torsion or patient non-compliance regarding choice and chewing of food.Immediate re-operation to remove the band is indicated if there is total stoma-outlet obstruction that does not respond to band deflation or if there is abdominal pain.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.Precautions: it is the responsibility of the surgeon to advise the patient of the dietary restrictions that follow this procedure and to provide diet and behavior modification support.Failure to adhere to the dietary restrictions may result in obstruction and/or failure to lose weight.Warnings: patients should be advised that the lap-band system is a long-term implant.Explant (removal) 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.

Event Description

Reported as: the patient had their lap-band system explanted, and reported the following events leading up to the removal: the patient felt they had eaten food that "became stuck in the band." the patient had experienced certain foods becoming stuck before, and in these previous times experienced gagging.This time that did not happen.The patient felt "sure the acids in [their] system would finally dissolve anything that was stuck over time.That did not happen.With nothing to eat or drink [for three days] there was no difference." the patient contacted their physician's office, who informed them to go to the hospital.The patient went to the emergency room where the physician checked the patient's x-rays, and said the band needed to be removed.The patient reported that after the surgery, they were "in tremendous pain, and did not know why, as [they were] told that removing the band was a lot easier than installing." the patient's physician told them they would "be very sore for a couple of days, as [the physician] had to cut about a 1" hole out of the stomach area to get the band and mesh out." the physician also told the patient they "could not get all the mesh out." the patient was told it "should be fine, and nothing else would be done.".

• 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: 5414305
• MDR Text Key: 37621358
• Report Number: 3006722112-2016-00042
• 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
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/08/2016

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2016
• Initial Date FDA Received: 02/05/2016
• 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