MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE); IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number UNK LAP-BAND

Device Problem Fluid/Blood Leak (1250)

Patient Problems Abdominal Pain (1685); Erosion (1750); Edema (1820); Fatigue (1849); Unspecified Infection (1930); Pain (1994); Pleural Effusion (2010); Pneumonia (2011); Pneumothorax (2012); Tachycardia (2095); Electrolyte Imbalance (2196); Weight Changes (2607)

Event Date 07/28/2014

Event Type  Injury  

Manufacturer Narrative

Taper ii.The reporter of the complaint was asked to return the product for analysis.The device has not yet been received by allergan.Based upon the implant and event date provided by the reporter the connector type is assumed to be a taper ii.Visual examination may determine the connector type associated with this report.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Complications related to procedure/surgery, cardiac complications, infection, hemorrhage, pneumothorax, gastric erosion, pain, vomiting, inflammation/irritation, fatigue, electrolyte imbalance, and unsatisfactory weight loss are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.No additional information has been reported to allergan regarding the catalog number, serial number, patient data or further event details.Device labeling addresses the possible outcome of leakage as follows: "deflation of the band may occur due to leakage from the band, the port or the connector tubing." device labeling addresses the reported event of complications related to procedure/surgery, cardiac complications and pneumothorax as follows: "the lap-band® system is contraindicated in: 2.Patients with severe cardiopulmonary diseases or other serious organic disease which may make them poor surgical candidates.2.It is the responsibility of the surgeon to advise the patient of the known risks and complications associated with the surgical procedure and implant." 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." caution: elevated homocysteine levels have been found in patients actively losing weight after obesity surgery.Supplemental folate and vitamin b12 may be necessary to maintain normal homocysteine levels.Elevated homocysteine levels may increase cardiovascular risk and the risk of neural tube abnormalities.Device labeling addresses the reported event of infection, abdominal pain, hematemesis (hemorrhage and vomiting), inflammation/irritation as follows: there were additional occurrences of these events that were considered to be non-serious.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 dis-placement, port site pain, spleen injury, and wound infection.Device labeling addresses the possible outcome of erosion and unsatisfactory weight loss as follows: "caution: insufficient weight loss may be caused by pouch enlargement or more infrequently band erosion, in which case further inflation of the band would not be appropriate." device labeling addresses the potential of fatigue and electrolyte imbalance as follows: "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.".

Event Description

Patient's legal representative reported weight gain, pain the abdomen and an elevated white blood cell count.The physician discovered that the lap-band had "disintegrated into pieces and lodged in various parts the patient's body, including the esophagus and abdomen" per diagnostic testing.After device removal the patient was placed into an induced coma for nine days because of complications with the surgery.The patient remained hospitalized for "nearly two months" because of infection and pneumonia.The patient continues to have pain and abdominal problems as a result of the defective lap-band.Additional findings: patient's legal representative reported "erosion" first noticed when patient complained of "melenic stools", "hematemesis", and "fatigue".Patient had various diagnostic testing performed showing "high carbon dioxide and glucose", "high platelet count", "sinus tachycardia", "low calcium, total protein, and albumin", "diffuse infiltrates or edema and questionable left pleural effusion", legs "swelled", "bibasilar atelectasis versus consolidation with a small amount of right pleural fluid", "small left sided pneumothorax", and "area of inflammatory change (phlegm) in upper left quadrant".

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capital of texas hwy; building 1, suite 300; austin, TX 78748 ; 8555513123
• MDR Report Key: 5019477
• MDR Text Key: 23661011
• Report Number: 3006722112-2015-00254
• 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
• Report Date: 07/24/2015

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK LAP-BAND
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2015
• 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
• Patient Age: 52 YR
• Patient Weight: 78