MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND SYSTEM 10CM; ADJUSTABLE GASTRIC BAND

Model Number B-2220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Regurgitation (2259)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

Unknown taper type.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.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 "gerd/reflux and dysphagia." the device was removed.

Manufacturer Narrative

Taper ii.Supplement # 1 - medwatch sent to the fda on 25/jan/2019.Additional information: device evaluation summary: the device was returned to apollo for analysis, and visual examination noted the lap-band with access port i, taper ii was received.The band tubing was separated approximately 1 inch from the port tubing ss connector.Needle marks were observed on the port septum.White and brown particles were noted on the inner surface of the band ring.The band was noted to be separated in half near the band buckle the separated portion of the band with the buckle noted to be still strapped to the band belt.An air leak test was performed and leakage was observed from the band ring and shell.A fill inspection test was performed and no blockage was observed.Under microscopic analysis both ends of the separated band ring and shell and both ends of the band tubing were noted to have striated edges consistent with damage from a surgical tool.

• Brand Name: LAP-BAND SYSTEM 10CM
• 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
• MDR Report Key: 8179145
• MDR Text Key: 130849573
• Report Number: 3006722112-2018-00335
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020169
• UDI-Public: 10811955020169
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2007
• Device Model Number: B-2220
• Device Catalogue Number: B-2220
• Device Lot Number: 1064255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Date Manufacturer Received: 02/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 149