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

Device Problems Device Slipped (1584); Device Issue (2379)

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 09/22/2015

Event Type  malfunction  

Manufacturer Narrative

Unknown taper: the reporter of the event was asked to return the product for analysis and to provide clarification on the nature of the reported events.To date, apollo has not received the device, device information nor any additional complaint information.Without device or device serial, the taper type is unknown.If returned, visual examination may determine the taper type associated with this event.This events were reported by the patient.To date, apollo has been unable to confirm the reported events with the patient's physician other than the band slip.Based on the information provided thus far, a review of device labeling reveals: precautions: over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation.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.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.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.The manufacturer of the lap-band ap adjustable gastric banding system has designed, tested and manufactured it to be reasonably fit for its intended use.However, the lap-band ap system is not a lifetime product and it may break or fail, in whole or in part, at any time after implantation and notwithstanding the absence of any defect.Causes of partial or complete failure include, without limitation, expected or unexpected bodily reactions to the presence and position of the implanted device, rare or atypical medical complications, component fail.

Event Description

Reported as: a patient with the lap-band system was reported to have a port replacement "a few years back." the port was removed on (b)(6) 2015 and patient reports continued pain at the port site.Additionally patient has reported experiencing other health issues such as extreme fatigue, loss of concentration, body pain, anxiety, severe depression, extreme weight gain, vision change, insomnia, hair loss, dry skin, dizziness, migrains, constipation, difficulty swallowing, reflux, nausea.The patient in the voluntary report form noted that it is believed to be due to the breast implants.Since the patient has the lap-band, apollo is taking the conservative approach and reporting these events.Follow up with the patient's physician indicated the patient had a band slip and the device was reposition on (b)(6) 2016.Device remains implanted.

• 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
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 6124717
• MDR Text Key: 60798718
• Report Number: 3006722112-2016-00373
• 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,other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/27/2016

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/23/2016
• 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): Required Intervention
• Patient Age: 39 YR