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

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Internal Organ Perforation (1987); Scar Tissue (2060); Septic Shock (2068); Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

Unknown taper.Medwatch sent to the fda on 11/16/2016.This event was reported by the patient's spouse.To date, apollo has been unable to confirm the reported events with the patient's physician.Device labeling addresses the reported events as follows: precautions: as with gastroplasty surgeries, particular care must be taken during dissection and during implantation of the device to avoid damage to the gastrointestinal tract.Any damage to the stomach during the procedure may result in erosion of the device into the gi tract.Over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation.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.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.Infection can occur in the immediate post-operative period or years after insertion of the device.In the presence of infection or contamination, removal of the device is indicated.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 reported the system eroded in the stomach."[patient] was in a coma for 2 weeks due to septic shock.Patient had to carry a oxygen tank for 2 months.[patient] required 2 doses of morphine at her check ups." patient was told another surgery was needed to remove scar tissue.Patient already has a 12" scar due to the lap-band.

Manufacturer Narrative

Unknown taper.Supplement #1 - medwatch sent to the fda on 06-feb-2018.Device labeling addresses the event as follows: adverse event: ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.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.

Event Description

Additional information noted the device "migrated and peforated [the patient's] viscus.The lap band also caused an acute ulcer with perforation.".

• 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, ; CS
• Manufacturer Contact: laura lebouef ; 1120 s. capital of texas hwy; bldg. 1, ste. 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 6106724
• MDR Text Key: 60032323
• Report Number: 3006722112-2016-00339
• 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,Followup
• Report Date: 01/08/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2016
• Initial Date FDA Received: 11/16/2016
• Supplement Dates Manufacturer Received: 01/08/2018
• Supplement Dates FDA Received: 02/06/2018
• 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