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 Rheumatoid Arthritis (1724); Autoimmune Disorder (1732); Dysphagia/ Odynophagia (1815); Inflammation (1932); Sjogren's Syndrome (2073)

Event Date 01/28/2011

Event Type  Injury  

Manufacturer Narrative

Unknown taper.The reporter of the event was asked to return the product for analysis, and to indicate device serial number.The reporter did not have the device, and stated it may have been discarded, and did not know the device serial or catalog number.Without the device or further device information, the connecter type associated with this event cannot be determined.This event was reported by the patient.Apollo has requested further information from the patient's physician regarding the event description, diagnostic testing, and device information.To date, apollo has been unable to confirm the events with the physician or received additional information.Device labeling addresses the reported events as follows: contraindications the lap-band system is contraindicated in: patients with inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as crohn's disease.Patients or family members with a known diagnosis or pre-existing symptoms of autoimmune connective-tissue disease such as systemic lupus erythematosus or scleroderma.Precautions: although there have been no reports of autoimmune disease with the use of the lap-band system, autoimmune diseases/connective tissue disorders (i.E., systemic lupus erythematosus, sclero-derma) have been reported following long-term implantation of other silicone implants.However, there is no conclusive evidence to substantiate a relationship between connective-tissue disorders and silicone implants.Adverse events: ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.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.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.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.

Event Description

Reported by the patient via mw 5057841 as: "multiple autoimmune diseases, that came in suddenly and severe following lap-band installation.Rheumatoid arthritis, sjogrens, gastroparesis, dysphagia, food and skin allergies, chronic widespread inflammation.Band was removed." follow-up with the patient confirmed the original report.To date, apollo has been unable to confirm the events with the patient's physician.

• 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: 5317189
• MDR Text Key: 34069766
• Report Number: 3006722112-2015-00591
• 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: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/25/2015

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: 11/25/2015
• Initial Date FDA Received: 12/21/2015
• 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: 30 YR
• Patient Weight: 119