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

Device Problems Device Slipped (1584); Device Or Device Fragments Location Unknown (2590)

Patient Problems Erosion (1750); Incontinence (1928); Nausea (1970); Pain (1994)

Event Date 11/15/2015

Event Type  Injury  

Manufacturer Narrative

Unknown taper.Medwatch sent to fda on 03/24/2016.This complaint was reported by the patient.Further information regarding the event description, dates of diagnostic testing, patient information, and device information has yet to be obtained from the patient's physician.To date, apollo has been unable to confirm the events with the physician or received any additional information.Device labeling addresses possible outcomes of band slip, nausea, pain, and erosion 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.Perforation of the stomach can occur.Death can also occur.Specific complications of laparoscopic surgery can include spleen damage (sometimes requiring splenectomy) or liver damage, bleeding from major blood vessels, lung problems, thrombosis, and rupture of the wound.Band slippage and/or pouch dilatation can occur.Gastroesophageal reflux, nausea and/or vomiting with early or minor slippage may be successfully resolved by band deflation in some cases.More serious slippages may require surgery to reposition and/or remove the band.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.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.Nausea and vomiting may also be symptoms of stoma obstruction or a band/ stomach slippage.Frequent, severe vomiting can result in pouch dilatation, stomach slippage or esophageal dilatation.Deflation of the band is immediately indicated in all of these situations.Deflation of the band may alleviate excessively rapid weight loss and nausea and vomiting.Reoperation to reposition or remove the device may be required.

Event Description

Reported as: a patient with the lap-band system was reported to have "three months ago had problems swallowing.Was nauseated, had pain and discomfort in the area where the band slipped.Eventually had emergency surgery to remove the band and it was complicated and long due to the corrosion of the band and it had embedded into stomach tissue.Fifteen day hospital stay, then to skilled nursing facility, functionality with gj tube now.".

Manufacturer Narrative

Supplement #1 medwatch sent to the fda on 03/31/2017.Device labeling addresses the reported additional events as follows: precautions: insufficient weight loss may be caused by pouch enlarge-ment or, more infrequently, band erosion in which case further inflation of the band would not be appropriate.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.

Event Description

Additional information provided by the patient: "i lost some weight initially then nothing." the physician agreed the band had slipped and ordered chest and abdomen x-rays as the patient reported pain.A ct scan was also performed on the abdomen.The patient had emergency surgery and reported "there is still a remnant left that the [physician] couldn't get out." after the surgery the patient reported that they lost both bladder and bowel control.A total of seventeen days were spent in the hospital.

• 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, ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. captial tx hwy; bldg. 1 suite 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5524604
• MDR Text Key: 41118106
• Report Number: 3006722112-2016-00050
• 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
• Type of Report: Initial,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• 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: 03/03/2017
• 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