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 Dysphagia/ Odynophagia (1815); Nausea (1970); Vomiting (2144); Weight Changes (2607)

Event Date 11/08/2017

Event Type  Injury  

Manufacturer Narrative

Unknown taper.The reporter of the event was asked to return the product for analysis, and to indicate product serial number.To date, neither the device nor any further device information has been received by apollo.Without device or device serial, the taper type is unknown.If returned, visual examination may determine the connector type associated with this event.Device labeling addresses the reported event as follows: 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.Ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.Nausea and vomiting may occur, particularly in the first few days after surgery and when the patient eats more than recommended.Nausea and vomiting may also be symptoms of stoma obstruction or a band/ stomach slippage.Frequent, severe vomiting can result in pouch dilatation, stomach slippage or esophageal dilatation.Deflation of the band is immediately indicated in all of these situations.Deflation of the band may alleviate excessively rapid weight loss and nausea and vomiting.Reoperation to reposition or remove the device may be required.Warnings: patients should be advised that the lap-band ap® 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

Reported as: a patient with the lap-band system was reported to have "trouble maintaining weight, dysphagia, intermittent nausea and vomiting." the device was removed.

Manufacturer Narrative

Taper ii.Supplement #1 - medwatch submitted to the fda on 07/jun/2018.Device evaluation summary: the device was returned to apollo for analysis, and visual examination confirmed the connector type as taper ii.Needle marks were noted on the port septum and port housing.Yellow particles were present on the port base.Red particles were observed on the band tubing.Light brown discoloration was observed on the band ring.An air leak test was performed and the device was noted to be leaking from an opening on the band shell at the shell-belt junction.A fill inspection test was performed and no blockage was observed.Under microscopic analysis, non-penetrating nicks were observed on the port housing and port base.Both ends of the separation on the band shell and ring, situated near the shell-belt junction, were noted to have striated edges, consistent with damage from a surgical tool.The end of the port tubing was noted to have striated edges, consistent with damage from a surgical end cut to remove the device.Non-penetrating nicks were observed on the port.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. capital 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, ; CS
• Manufacturer Contact: laura lebouef ; 1120 s. capital of texas hwy; bldg. 1, ste. 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 7317088
• MDR Text Key: 101614407
• Report Number: 3006722112-2018-00066
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 58 YR
• Patient Weight: 85