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

Model Number AP STANDARD

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/31/2015

Event Type  Injury  

Manufacturer Narrative

Taper ii medwatch sent to fda on: 11/03/2015.The device was returned for analysis, and only the band portion was received.Without the port, visual examination could not determine taper type.Based on the serial number provided, it is assumed the connecter type associated with this complaint is a taper ii.Device evaluation summary: the device was returned to apollo, and only the band portion of the lap-band system was received.Visual inspection observed a surgical end cut on the tubing, and the band appeared to be discolored.A fill inspection and leak test were performed, and no blockage or leak of the band was found.Device labeling addresses the reported event as follows: how supplied: the lap-band ap system is available in two sizes, standard and large.The physician should choose the appropriate size depending upon the patient's individual anatomy.Most patients with correctly fitted bands report minimal, if any, restriction following resolution post-operative edema until saline is added to the band, regardless of band size.The large band is normally used for re-operations (particularly conversion from other procedures) and the pars flaccida dissection.Surgeons are advised to evaluate the amount of tissue within the band prior to band locking and suturing in place, and, if it appears excessive, to remove some omental tissue or move the dissection closer to the stomach wall or higher on the stomach.Additional information regarding size selection is provided in the training program.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: the patient was not tolerating solids or liquids.The physician performed an adjustment and defilled the lap-band system to 0cc, however the patient saw no improvement.The patient's lap-band was explanted and replaced with a larger sized lap-band.

• Brand Name: LAP-BAND AP STANDARD WITH ACCESS PORT II
• 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: 5198957
• MDR Text Key: 30308663
• Report Number: 3006722112-2015-00482
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020220
• UDI-Public: 10811955020220
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/26/2014
• Device Model Number: AP STANDARD
• Device Catalogue Number: B-2260
• Device Lot Number: 2264665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2012
• 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: 47 YR
• Patient Weight: 71