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); Sepsis (2067); Bowel Perforation (2668); Patient Problem/Medical Problem (2688)

Event Date 05/01/2016

Event Type  Injury  

Manufacturer Narrative

Unknown taper.Medwatch sent to fda on 09/02/2016.This event was reported by the patient, and no contact information was provided for either the reporter or the reporter's physician.Apollo is therefore unable to confirm the reported events with the patient's physician, or gather additional information at this time.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.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 was reported to: "five years ago [my spouse] had an allergan lap band inserted into their stomach area.In 2016 [my spouse] became violently ill and i had to rush them to the emergency room.After a ct scan the on-call surgeon noticed the lap band eroded into the stomach lining and bowel area.Resulting in septic shock and immediate surgery.After surgery, their vitals became alarming and immediately put [the patient] on life support.After the surgery, the surgeon explained to me what happened.They said that the lap band was defected and/or the surgeon who did the installation of lap- band may have sutured it to the stomach lining causing erosion and septic shock.After looking at the procedure giving by allergan on a pdf available online, it clearly states that the lap band not be sutured to any part of the stomach.[my spouse] almost lost their life and now has permanent bowel problems causing them to miss work and a very uncomfortable feeling on a daily basis.".

• 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: 5925641
• MDR Text Key: 53842158
• Report Number: 3006722112-2016-00274
• 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
• Report Date: 08/09/2016

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: 08/09/2016
• Initial Date FDA Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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