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

Model Number AP STANDARD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Nausea (1970); Vomiting (2144); Foreign Body In Patient (2687)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

Taper ii.Medwatch sent to fda on 11/24/2015.The reporter of the event was asked to return the product for analysis, and indicate device serial number.To date, neither the device nor further device information has been received by apollo.Based on the catalog number and implant date provided, it is assumed to be a taper ii.If returned, visual examination may confirm or determine another connecter type associated with this complaint.The initial reporter was asked to provide further information regarding the event description, dates of diagnostic testing, patient information, and device information.To date, no additional information has been received by apollo.Device labeling addresses the reported event as follows: precautions: failure to create a stable, smooth path for the access port tubing, without sharp turns or bends, can result in tubing breaks and leakage.In order to avoid incorrect placement, the port should be placed lateral to the trocar opening.A pocket must be created for the port so that it is placed far enough from the trocar path to avoid abrupt kinking of the tubing.The tubing path should point in the direction of the access port connector so that the tubing will form a straight line with a gentle arching transition into the abdomen.The lap-band ap system is for single use only.Do not use a band, access port, needle or calibration tube that appears damaged (cut, torn, etc.) in any way.Do not use any of the above components if the package has been opened or damaged or if there is any evidence of tampering.If packaging has been damaged, the product may not be sterile and may cause an infection.Care must be taken to avoid damaging the band, its inflatable section or tubing, the access port or the calibration tube.Use only rubber-shod clamps to clamp tubing.The band, access port and calibration tube may be damaged by sharp objects and manipulation with instruments.A damaged device must not be implanted.For this reason, a stand-by device should be available at the time of surgery.Failure to use the tubing end plug during placement of the band may result in damage to the band tubing during band placement.Failure to use an appropriate atraumatic instrument to lock the band may result in damage to the band or injury to surrounding tissues.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.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.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.

Event Description

Reported via mw 5056453 as: patient underwent laparoscopic adjustable gastric banding with no complications noted at the time of surgery.Post-operative upper gi series was performed and the impression was a normal postop lap-band study and patient discharged the following day.Some time after placement, the patient presented to the emergency department at another facility complaining of nausea/vomiting and described an aching pain in the left upper and lower quadrant of the abdomen.A ct of the abd/pelvis was performed which identified a small cylindrical foreign body within the posterior aspect of the pelvis on the left.The patient was transferred back to the facility that placed the lap-band for further work up.The patient was taken to the operating room for an exploratory laparoscopy, lysis of adhesions and removal of the foreign body.Upon elevating the right fallopian tube a small piece of white apparent foreign body was identified.This was removed and was noted to be approximately 1.5cm piece if the lap-band tubing without any evidence of infection or any other pathology.Patient was discharged without any complications.Upon inspection, the foreign body appears to be the tip of the lap-band ap system that appears to have broken off.

• 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: 5248780
• MDR Text Key: 32091369
• Report Number: 3006722112-2015-00566
• 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,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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