MAUDE Adverse Event Report: RESHAPE LIFESCIENCES LAP-BAND SYSTEM; ADJUSTABLE GASTRIC BAND

Device Problems Material Erosion (1214); Device Slipped (1584)

Patient Problems Chest Pain (1776); Vomiting (2144); Regurgitation (2259)

Event Date 03/12/2018

Event Type  Injury  

Manufacturer Narrative

Unknown taper.This event was reported by the patient.The reporter of the event was asked to indicate product serial number and return the product for analysis.To date, no device information has been received by apollo and has been unable to confirm the reported events with the patient's physician.Device labeling addresses the reported event as follows: precautions: it is the responsibility of the surgeon to advise the patient of the known risks and complications associated with the surgical procedure and implant.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.Revision procedures may require the existing staple line to be partially disrupted to avoid having a second point of obstruction below the band.As with any revision procedure, the possibility of complications such as erosion and infection is increased.Any damage to the stomach during the procedure may result in peritonitis and death or in late 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.Ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.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.Reoperation for band erosions may result in a gastrectomy of the affected area.Eroded bands have been removed gastroscopically in a very few cases.Consultation with other experienced lap-band® system surgeons is strongly advised in these cases.Nausea and vomiting may occur, particularly in the first few days after surgery and when the patient eats more than recommended.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.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: failure to secure the band properly may result in its subsequent displacement and necessitate a second operation.The band should not be sutured to the stomach.Suturing the band directly to the stomach may result in erosion.Patients should be advised that the lap-band ap® 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.

Event Description

Reported as: a patient with the lap-band system reported "lap-band had slipped, eroded in [patient's] stomach and embedded into [patient's] liver causing, vomiting, gerd and extreme chest pain." device was removed.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente 92673
• Manufacturer (Section G): ALLERGAN; global park free zone; 900 global park; la aurora de heredia
• Manufacturer Contact: kristin wielenga ; 1001 calle amanecer; san clemente, CA 92673 ; 9494817851
• MDR Report Key: 8391179
• MDR Text Key: 137850025
• Report Number: 3013508647-2019-00006
• 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: 02/08/2019

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 03/05/2019
• 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; Life Threatening; Required Intervention