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

Device Problems Fluid/Blood Leak (1250); Migration (4003)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Unspecified Infection (1930); Internal Organ Perforation (1987); Tachycardia (2095); Cardiac Tamponade (2226); Loss of consciousness (2418); Bronchopneumonia (2437); Irregular Pulse (2469)

Event Date 01/01/2008

Event Type  malfunction  

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.The manufacturer of the device is unknown.Without device or device serial, the taper type 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.In revision procedures the existing staple line may need 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.Care must be taken during band adjustment to avoid puncturing the tubing that connects the access port and band, as this will cause leakage and deflation of the inflatable section.Failure to create a stable, smooth path for the access port tubing, without sharp turns or bends, can result in tubing breaks and leakage.In order to avoid incorrect placement, the port should be placed lateral to the trocar opening.A pocket must be created for the port so that it is placed far enough from the trocar path to avoid abrupt kinking of the tubing.The tubing path should point in the direction of the access port connector so that the tubing will form a straight line with a gentle arching transition into the abdomen.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.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.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.Deflation of the band may occur due to leakage from the band, the port or the connecting tubing.Rapid weight loss may result in development of cholelithiasis which may result in the need for a cholecystectomy.Warnings: failure to secure the band properly may result in its subsequent displacement and necessitate reoperation.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.Patients must be carefully counseled on the need to report all vomiting, abdominal pain or other gastrointestinal or nutritional issues as these symptoms may indicate a condition not related to the lap-band® system.

Event Description

Reported event from journal article titled: "polymicrobial bacterial pericarditis and cardiac tamponade caused by pericardial penetration of an adjustable gastric band" summary of events; a laparoscopic adjustable gastric band (lagb) patient presented at the emergency department complaining of acute dyspnea and a pounding retrosternal pain radiating to the back that increased during inspiration.Patient had lagb in 2003.Five years later, patient experienced a leak in the lagb.Physician performed a banded gastric bypass leaving the original band and 2 cm of the catheter in situ around the gastric pouch as a banded bypass.The port and remaining catheter was cut and removed.In 2011, a computed tomography (ct) scan was performed due to patient experiencing abdomen pain which showed signs of cholecystitis.The proximal tip of the catheter connected to the gastric band was located caudally of the left lobe of the liver.The patient underwent cholecystectomy.Three months thereafter, an abdominal ct scan was performed which showed that the proximal tip of the catheter had migrated inwards the left lobe of the liver.The patient was in pain but alert and fully oriented.A ct angiography was performed which showed bilateral basal atelectasis, but no signs of aortic dissection or pulmonary embolism.The patient was diagnosed with a bilateral pneumonia and was admitted to the hospital and treated with oral amoxicillin.Two days after admission, patient's condition deteriorated.There were bibasal crackles in the lungs, and the heart tones were barely audible, but a third heart tone was clearly heard.An electrocardiography (ecg) showed a sinus tachycardia and an emergency echocardiography showed pericardial effusion suggestive for pericarditis.The patient was transferred to the coronary care unit (ccu).A short time after arrival on the ccu, patient developed an irregular heart rhythm and an immeasurable blood pressure.The patient lost consciousness which was thought to be caused by a cardiac tamponade.An emergency pericardiocentesis was performed, and 600ml of purulent fluid was aspirated.A drain was left in situ.Following this drainage, the patient's condition improved markedly.Analysis of the fluid showed an exudate, with low glucose concentration and a high amount of neutrophils.Cultures showed an infection with both proteus mirabilis and klebsiella pneumoniae.Another ct scan was performed which demonstrated that the distal tip of the lagb catheter, located caudally of the liver in 2011 was now penetrating the pericardium and was in contact with the myocardium.As the clinical condition of the patient improved, patient underwent a laparotomy to remove the lagb.During surgery, the surgeon confirmed that the proximal tip of the lagb perforated the pericardium and was residing in the pericardial space.The pathway through which the catheter had migrated was readily visible.Thorough examination revealed no other lacerations.The gastric band and the catheter were removed.The patient received antibiotic treatment, and improved clinically, however, was subsequently operated on thrice for gall leakage for which no clear cause could be determined.Examination of the liver and bile ducts showed no other abnormalities than the path the catheter had traversed.After a total hospital stay of 45 days, patient was discharged from the hospital and remains till now in good clinical condition.Although the manufacturer of the device is unknown, it is apollo's approach to compliance to resolve all doubt in favor of reporting.

Manufacturer Narrative

• 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
• MDR Report Key: 7953501
• MDR Text Key: 124984559
• Report Number: 3006722112-2018-00256
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/10/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 09/10/2018
• Supplement Dates FDA Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMOXICILLIN; CEFUROXIME; CIPROFLOXACIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR