MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND AP STANDARD W/ ACCESS PORT I; ADJUSTABLE GASTRIC BAND

Model Number B-2240

Device Problem Device Slipped (1584)

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Erosion (1750); Diarrhea (1811); Dysphagia/ Odynophagia (1815); Unspecified Infection (1930); Swelling (2091); Vomiting (2144); Hernia (2240); Blood Loss (2597); Fluid Discharge (2686)

Event Date 11/28/2017

Event Type  Injury  

Manufacturer Narrative

Unknown taper.This event was reported by the patient.The reporter was asked to return the product for analysis.To date, apollo has not received the device.If returned, visual examination may confirm or determine the taper type associated with the reported event.Review of the device labeling notes the following: 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.Anti-inflammatory agents, such as aspirin and nonsteroidal anti-inflammatory drugs (nsaids), may "irratate" the stomach and should be used with caution.The use of such medications may be associated with an increased risk of erosion.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.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.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 had experienced difficulty with swallowing, diarrhea and had the device removed due to device erosion which corroded into the stomach.An esophagogastroduodenoscopy (egd) confirmed erosion.During the explant surgery, it was noted the band had slipped and had gone far down the stomach.Physician had to cut the stomach to find the band.A month later, the patient reported pain, swelling and drainage with grey output with foul smell at incision site.Patient had opening of the wound.Operative report confirmed infection and drainage of wound abscess.Later patient had reported concern of bleeding from the incision site, pain around abdomen and discomfort away from incision site.Per operative report, the discomfort was due to muscular bruising that often show up several weeks after the procedure.The patient was hospitalized for abdominal pain.The infection had damaged the muscle in the stomach and caused a huge hernia.Computed tomography (ct) scan confirmed 6.8 centimeter incisional hernia defect in the upper midline.The hernia was pushing the intestines and ovaries and therefore the patient had the hernia repair surgery.This experience has "changed/bothered [patient] mentally", even though the lap-band was very helpful to the patient for a long time with the patient's eating habits and help to lose 180 lbs.

Event Description

Follow up findings per operative report: patient additionally experienced vomiting.

Manufacturer Narrative

Review of the device labeling notes the following: 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.

• Brand Name: LAP-BAND AP STANDARD W/ ACCESS PORT I
• 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
• MDR Report Key: 8197031
• MDR Text Key: 131421711
• Report Number: 3006722112-2018-00328
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020183
• UDI-Public: 10811955020183
• 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: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2013
• Device Model Number: B-2240
• Device Catalogue Number: B-2240
• Device Lot Number: 2085767
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DAKIN SOLUTION; PERCOCET; DAKIN SOLUTION; PERCOCET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 100