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

Device Problem Insufficient Information (3190)

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

Event Date 06/16/2017

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.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 "chronic issues of dysphagia/gerd." device has been removed.

Manufacturer Narrative

Taper ii: device evaluation summary: the device was returned to apollo for analysis, and visual examination confirmed the connector type as taper ii.The lap-band, access port i, taper ii and tubing were all returned.The port tubing was separated approximately 1.5 inches from the stainless steel connector.Scratches were noted on the port housing and port holes.Needle marks were noted on the port septum.The buckle and a small portion of the band ring were noted to be missing from the lap-band.The band tubing was separated approximately 20.0 inches from the tubing collar/junction.A fill inspection test was performed, and no blockage was noted when colored di water was passed through the port septum, and also through the port tubing.An air leak test was not feasible, as the band was cut in half, near the buckle.Under microscopic analysis, end of the separated band, both ends of the band tubing, and both ends of the port tubing all had striated edges, consistent with surgical end cuts to remove the device.A portion of the buckle and band ring were not returned.Brown and black particulate matter was noted at the junction of the port housing and port septum.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital tx hwy; bldg. 1 suite 300; austin TX 78746
• Manufacturer (Section G): ALLERGAN; global park free zone; 900 global park; la aurora de heredia, ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. captial of texas hwy; bldg 1, ste. 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 7004973
• MDR Text Key: 91185420
• Report Number: 3006722112-2017-00365
• 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: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• 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: 12/29/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2018
• 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: 46 YR
• Patient Weight: 96