MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND AP STANDARD W/ ACCESS PORT I; ADJUSTABLE GASTRIC BAND

Model Number B-2240

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

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 09/21/2016

Event Type  Injury  

Manufacturer Narrative

Unknown taper, medwatch sent to the fda on 11/30/2016.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 possible event of dysphagia 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 device removal due to "dysphagia".

Manufacturer Narrative

Supplement #1: medwatch sent to fda on 03/07/2017.Additional information: report date, brand name, model #/lot #, device available for evaluation?, date received by mfr?, type of reports, if follow-up, what type?, device evaluated by mfr?, device manufacture date, evaluation codes.

Manufacturer Narrative

Taper i.Device evaluation summary: the device was returned to the apollo device analysis laboratory and a visual inspection was performed on the received lap-band with access port i, taper i.The lap-band ring and the shell were noted to be discolored, brown in color.White particles were noted on the outer surface of the lap-band shell.The access port tubing was noted to be discolored, also brown in color.A portion of the band tubing was still connected to the access port ss connector.Needle marks were noted on the port septum and port holes.A fill inspection test was performed, and no blockage was noted when di water was passed through the port septum and port tubing.An air leak test was performed, and no leakage was noted.The end of the port tubing and band tubing had striations, consistent with a surgical end cut.

• Brand Name: LAP-BAND AP STANDARD W/ ACCESS PORT I
• 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
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795100
• MDR Report Key: 6136531
• MDR Text Key: 61167562
• Report Number: 3006722112-2016-00364
• 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,Followup
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/08/2009
• Device Model Number: B-2240
• Device Catalogue Number: B-2240
• Device Lot Number: 1470371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2007
• 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: 68 YR
• Patient Weight: 99