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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Flatus (1865); Pain (1994); Regurgitation (2259)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

This event was reported by the patient.To date, apollo has been unable to confirm the reported events with the patient's physician, or obtain additional information such as device serial number, implant and explant dates, and if the device is available for return.Without device or device serial, the taper type is unknown.If returned, visual examination may determine the connector type associated with this event.Device labeling addresses the reported events as follows: 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.Ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.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.Other adverse events considered related to the lap-band system that occurred in fewer than 1% of subjects included: esophagitis, gastritis, hiatal hernia, pancreatitis, abdominal pain, hernia, incisional infection, infection, redundant skin, dehydration, gi perforation, diarrhea, abnormal stools, constipation, flatulence, dyspepsia, eructation, cardiospasm, hematemesis, asthenia, fever, chest pain, incision pain, contact dermatitis, abnormal healing, edema, paresthesia, dysmenorrhea, hypochromic anemia, band leak, cholecystitis, esophageal dysmotility, esophageal ulcer, esophagitis, port displacement, port site pain, spleen injury and wound infection.

Event Description

Reported as: a patient with the lap-band system was reported to have: "never had success with the band, no matter how hard they tried.They started having some issues with the band: severe gas, pain while sitting upright, and reflux.They spent a year in constant pain.Finally got some tests [which] the surgeon said, according to the test the band is there and then when you look at it from 360 view the band disappears, so they were told they needed to cut the patient open and see what was going on.[the] band was completely inside the stomach, which took removal and surgery to the stomach.The patient is still having problems, which we at this time don't know exactly what it is.An egd is scheduled as the doctor believes there is damage from the band." the patient's lap-band system was explanted.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. captial 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 ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. capital of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5631337
• MDR Text Key: 44401648
• Report Number: 3006722112-2016-00110
• 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
• Type of Report: Initial
• Report Date: 04/06/2016

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
• Initial Date Manufacturer Received: 04/06/2016
• Initial Date FDA Received: 05/04/2016
• 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): Required Intervention