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

Device Problems Filling Problem (1233); Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Pain (1994); Perforation (2001); Tachycardia (2095); Regurgitation (2259); Malaise (2359); Coma (2417); Weight Changes (2607)

Event Date 02/02/2015

Event Type  Injury  

Manufacturer Narrative

Unknown taper.The product associated with this complaint will not be returned.Information regarding device serial number has been requested of the initial reporter, no information has been received by apollo to date.Without device serial, catalog, or model information, the connector type associated with this complaint cannot be determined.This event was reported by the patient, and to date apollo has been unable to confirm the events with the patient's physician.Device labeling addresses the reported event as follows: adverse events: 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.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 warnings: patients should be advised that the lap-band 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

Patient reported: they were contacted by their physician and asked to come in and have their lap-band evaluated, since many of the physician's patients were having issues and requiring explant.The lap-band was explanted, and after the initial surgery the patient's condition deteriorated.Patient was taken back into surgery and told by their physician the band ripped a hole in their stomach.Patient was put into a coma, patient thinks it was because of the severe pain they were in.Patient stayed in the hospital for 50 days.Their family was told by the nurses that the patient had a 50/50 chance of survival.After they were discharged, patient reports they were weak, could hardly walk (required a walker), and could not do everyday tasks.

Manufacturer Narrative

Supplement #1 sent to fda 02/09/2016.Labeling evaluation based on additional information.Device labeling addresses the reported event as follows: "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." "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.".

Event Description

Follow up that was performed with the physician's office found that the patient originally presented with gerd in (b)(6) of 2014, and unsatisfactory weight loss, after not being seen in the office for the last 3-4 years.The pouch was believed to be prolapsed, and the health professional was unable to retrieve fluid.Removal was scheduled to address these issues, and in addition the patient no longer wished to have their lap-band.After removal of the lap-band, a small area of erosion was noted on the stomach.While in recovery, it was noted the patient developed tachycardia, and a perforation of the stomach was observed and repaired.The patient then developed an abscess in her stomach, and suffered from delirium while hospitalized.She was then discharged when symptoms ultimately resolved.The device information remains unknown.The explanted device is not available for return.

• 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, costa rica, cs ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. capital of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5102133
• MDR Text Key: 26717239
• Report Number: 3006722112-2015-00387
• 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: Followup
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2016
• 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; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 107