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

Model Number AP STANDARD

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/11/2016

Event Type  Injury  

Manufacturer Narrative

Taper ii.The reporter of the event was asked to return the product for analysis, and to indicate product serial number.To date, apollo has not received the device nor any further device information.Based on the catalog number provided, it is assumed the connecter type is a taper ii.If returned, visual examination may confirm or determine another taper type associated with this event.Further information regarding the event, dates of diagnostic testing, patient information, and device information have been requested of the initial reporter.To date, no additional information has been received by apollo.Device labeling addresses the reported events as follows: adverse events: unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.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.Warnings: patients should be advised that the lap-band 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 had their lap-band system explanted "due to leaking band seen on fluoroscopy." the physician reported the lap-band was explanted and replaced, and noted a "crack to the band hub seen during surgery.".

Manufacturer Narrative

Supplement #1 - medwatch sent to fda on 04/01/2016.Device evaluation summary: the device was returned for analysis, and visual examination confirmed the connector type as taper ii.A visual inspection was performed on the device, and noted the shell to be discolored, and brown in color in areas.Yellow particles were noted on the outer surface of the port tubing junction/band tubing.The port was air leak tested, and noted to be leaking from the tubing, from an area which appeared worn.Wear and thinning was observed on the band shell.Wear and thinning was also noted on the port tubing.A fill test inspection was performed, and no blockage or resistance to flow was noted.A microscopic analysis was performed, and noting a smooth opening on the band tubing.

• Brand Name: LAP-BAND AP STANDARD WITH 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, costa rica, cs ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. capital of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5429373
• MDR Text Key: 37962215
• Report Number: 3006722112-2016-00023
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020183
• UDI-Public: 10811955020183
• 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: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: AP STANDARD
• Device Catalogue Number: B-2240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2016
• 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: 38 YR
• Patient Weight: 76