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

Model Number AP STANDARD

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Vomiting (2144); Regurgitation (2259); Anxiety (2328); Weight Changes (2607)

Event Date 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

Taper ii.Medwatch sent to fda on 11/24/2015.Device evaluation summary: the device was returned for analysis, and visual examination confirmed the connecter type as taper ii.Visual inspection noted the device shell was discolored, and the tubing appeared to have been surgically cut.Leak testing was performed and observed no leakage of the device.A fill test was performed and no blockage was observed.Analysis of the device noted striations on the tubing cuts consistent with surgical damage.Device labeling address the reported event as follows: precautions: care must be taken to place the access port in a stable position away from areas that may be affected by significant weight loss, physical activity or subsequent surgery.Failure to do so may result in the inability to perform percutaneous band adjustments.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.Nausea and vomiting may occur, particularly in the first few days after surgery and when the patient eats more than recommended.Nausea and vomiting may also be symptoms of stoma obstruction or a band/ stomach slippage.Frequent, severe vomiting can result in pouch dilatation, stomach slippage or esophageal dilatation.Deflation of the band is immediately indicated in all of these situations.Deflation of the band may alleviate excessively rapid weight loss and nausea and vomiting.Reoperation to reposition or remove the device may be required.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 the lap-band system placed, and reported losing and regaining weight.The patient complained of reflux and occasional vomiting.The patient reported to their physician they eat small meals multiple times a day but still experience problems.The physician made attempts to access the band, and the patient had an x-ray with results that were unclear.The physician reported the port was flipped.The patient stated to their physician they want their band removed, their reflux and vomiting have not improved which is causing them anxiety and affecting their quality of life.The lap-band system was explanted.

• 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
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5247673
• MDR Text Key: 32071520
• Report Number: 3006722112-2015-00568
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/04/2011
• Device Model Number: AP STANDARD
• Device Catalogue Number: B-2240
• Device Lot Number: 1753579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2009
• 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 Age: 42 YR
• Patient Weight: 111