MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND SYSTEM 10CM; ADJUSTABLE GASTRIC BAND

Model Number B-20220

Device Problems Device Slipped (1584); Migration (4003)

Patient Problems Wound Dehiscence (1154); Erosion (1750); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Fever (1858); Nausea (1970); Pain (1994); Sepsis (2067); Tachycardia (2095); Vomiting (2144); Chills (2191); Malaise (2359); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); Constipation (3274)

Event Date 04/15/2018

Event Type  Injury  

Manufacturer Narrative

Unknown taper type.The device has noted to be discarded and will not be returned for analysis.Without the device, the taper type connector will be unknown.Device labeling addresses the reported events as follows: precautions: over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation.Anti-inflammatory agents, which may irritate the stomach, such as aspirin and non-steroidal anti-inflammatory drugs, 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.Ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.Slippage and/or pouch dilatation of the band can occur.Gastroesophageal reflux, nausea and/or vomiting with early or minor slippage may be in some cases successfully resolved by band deflation.More serious slippages may require band repositioning and/or removal.If there is total stoma outlet obstruction that does not respond to band deflation, or if there is abdominal pain, then immediate re-operation to remove the band is indicated.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.Symptoms of band erosion may include reduced weight loss, weight gain, access port infection, or abdominal pain.Reoperation to remove the device is required.Re-operation 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 lapband® 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.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.Other adverse events considered related to the lap-band® system that occurred in fewer than 2% of study patients included: diarrhea (n=2), gastric pouch dilatation (n=2), gastritis (n=2), esophageal dilatation (n=2), syncope (n=2), seroma (n=2).Other events reported to occur in only one patient per event included; abdominal discomfort, alopecia, anemia, arthralgia, decrease blood folate, flatulence, gastrointestinal motility disorder, bronchitis, chills, implant site infection, implant site irritation, implant site hemorrhage, night sweats, hypotrichosis, headache, nail infection, pyrexia, skin irritation, esophageal obstruction, esophageal spasm, postoperative infection, urinary tract infection, muscle spasms, depression, back pain, and hypertension.Warnings: patients should be advised that the lap-band ap system is a long-term implant.Explant 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.The band should not be sutured to the stomach.Suturing the band directly to the stomach may result in erosion.

Event Description

Reported as: a patient with the lap-band system had experienced difficulty swallowing and noted food would get stuck in the esophagus.Patient would need to throw up food and described the band as feeling tight with the port site being uncomfortable.Patient went to the physician and an x-ray was performed.The image noted the band had slipped and the port had flipped.The physician was unable to access the port to release fluid, so it was determined that the device needed to be removed.The patient had the device removed one month later and during removal it was observed that the device had eroded into the stomach.After removal, the patient noted that the port site was not sutured up, but another method for recovery was used.Approximately a week after removal, the patient awoke one night to the "smell of rotting flesh" and noticed a puddle of blood coming from the port site.Patient went to the physician and it was confirmed that the wound was infected.They applied gauze to treat the wound/infection.The patient went home and started to experience body aches, fever (up to 104) and chills.This continued for a week and then the patient went to the emergency room.The patient was diagnosed with sepsis and was admitted to the hospital for ten days.The patient confirmed that during this time they were throwing up bile, the stomach was swollen with gas and patient was constipated.In review of medical records it was additionally noted: patient had lap-band removed which was then complicated by surgical site infection.Associated symptoms included anorexia, nausea, chills, fever, and malaise.Patient was admitted for sepsis and post-operative infection.It was noted that the patient was seen three times for wound care prior to hospitalization.Patient has had some dyspnea, exacerbated breathing and mild tachycardia.Patient was doing well; however, approximately five days into the hospital stay the patient started to get abdominal distention, nausea and vomiting.A ct scan showed a small bowel obstruction which improved on its own.Final diagnosis was sepsis secondary to post-operative infection.

• Brand Name: LAP-BAND SYSTEM 10CM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital 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. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 8363578
• MDR Text Key: 136922643
• Report Number: 3006722112-2019-00055
• 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,health professional
• Type of Report: Initial
• Report Date: 01/23/2019

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
• Device Expiration Date: 12/04/2010
• Device Model Number: B-20220
• Device Catalogue Number: B-20220
• Device Lot Number: 1689389
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2008
• 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
• Patient Age: 26 YR
• Patient Weight: 76