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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Pain (1994); Pleural Effusion (2010); Ulcer (2274); Obstruction/Occlusion (2422); Hematuria (2558); Ascites (2596); Cancer (3262)

Event Type  Death  

Manufacturer Narrative

Unknown taper.The reporter of the event was asked if the product was available for analysis and to provide device information.Reporter confirmed no further information available.Without device or device serial, the taper type is unknown.The device manufacturer of the device is unknown.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.Patients must be carefully counseled on the need for proper dietary habits.They should be evaluated for nutritional (including caloric) needs and advised on the proper diet selection.The physician may choose to prescribe appropriate dietary supplements.Appropriate physical monitoring and dietary counseling should take place regularly.Patients must be seen regularly during periods of rapid weight loss for signs of malnutrition, anemia or other related complications.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.Ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.Obstruction of stomas has been reported as both an early and a late complication of this procedure.This can be caused by edema, food, improper initial calibration, band slippage, pouch torsion or patient non-compliance regarding choice and chewing of food.Rapid weight loss may result in symptoms of malnutrition, anemia and related complications (i.E., polyneuropathies).Deflation of the band may alleviate excessively rapid weight loss.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: laparoscopic or laparotomic placement of the lap-band ap® system is major surgery and death can occur.

Event Description

Reported event from journal article titled: "gastric cancer in a patient with laparoscopic adjustable gastric band: case report and review of literature" summary of events; a laparoscopic adjustable gastric band (lagb) patient with past medical history of morbid obesity presented to the emergency room with acute onset of pain in the right flank.Physical exam was significant for tenderness in the right costo-vertebral angle.In addition to this, a 2×2 cm pink colored umbilical nodule was noted.On further questioning, the patient reported 30-lbs weight loss over last year, which patient attributed to lagb and hence did not seek care.The labs at presentation were only remarkable for macroscopic hematuria.Computed tomography (ct) scan of the abdomen showed large ascites and three small kidney stones in the right kidney.An esophago-gastro-duodenoscopy (egd) done in search of the primary site for malignancy showed a 1.5-cm large ulcer on the proximal body of greater curvature along with infiltration along the edges.The histopathology from the biopsy of this ulcer showed adenocarcinoma with signet ring cells, which led to the diagnosis of gastric cancer, advanced gastrointestinal (gi) malignancy.Staging ct scans showed small bilateral pleural effusion and multiple omental nodules.After 4 cycles of chemotherapy, patient presented with severe nausea, vomiting, and rapid expansion of abdominal girth.Repeated ct scans showed worsening of ascites and increase in peritoneal involvement with the tumor.Patient was diagnosed with mechanical small bowel obstruction secondary to peritoneal carcinomatosis.Conservative measures like naso-gastric tube and bowel rest failed to relieve patient's obstruction.At this point, a discussion was held with the patient and patient's family where they opted for hospice care.Patient passed away after 4 months since the diagnosis of cancer.Although the manufacturer of the device is unknown, it is apollo's approach to compliance to resolve all doubt in favor of reporting.

• 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
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795100
• MDR Report Key: 7930580
• MDR Text Key: 122512133
• Report Number: 3006722112-2018-00250
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/03/2018
• 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
• Treatment: 5-FLUOROURACIL; FLUOROURACIL BOLUS; LEUCOVORIN RESCUE; OPIOID ANALGESICS; OXALIPLATIN
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 50 YR