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

Catalog Number B-2240

Device Problem Obstruction of Flow (2423)

Patient Problems Erosion (1750); Dehydration (1807); Dysphagia/ Odynophagia (1815); Pain (1994); Vomiting (2144); Regurgitation (2259); Malaise (2359)

Event Date 03/21/2016

Event Type  Injury  

Manufacturer Narrative

Unknown taper medwatch sent to fda on 04/27/2016.The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.If returned, visual examination may confirm or determine the taper type associated with this event.Device labeling addresses possible outcomes of intolerance, band erosion, dysphagia, reflux, vomiting, pain and difficulty adding/removing saline as follows: warning: over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation.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.There is a risk of band erosion into stomach tissue.Erosion of the band into stomach tissue has been associated with revision surgery after the use of gastric-irritating medications, after stomach damage and after extensive dissection or use of electrocautery, and during early experience.Symptoms of band erosion may include reduced weight loss, weight gain, access port infection or abdominal pain.Reoperation to remove the device is required.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.Caution: when adjusting band volume, the needle must be inserted perpendicular to the access port septum.Failure to do so may cause damage to the port and result in leaks.

Event Description

Reported as: a patient with the lap-band system was reported to have "had no issues with the device until recently when they couldn't keep liquids or solids down.A ct scan was performed along with a diagnostic endoscopic procedure which showed the band had eroded into the stomach.The patient had the lagb system removed." additional information reported by the physician: "it is reported that two days prior to admittance the patient began to have difficulty swallowing solids and some difficulty with liquid associated with incidental heartburn." it was noted: "a rather small gastric pouch was identified and at the waist, i get the subtle sense that the buckle of the band has eroded through the mucosa." i did try accessing her port, was unable to retrieve any saline from the device." the patient was admitted for device removal.It was noted that the patient appears "rather uncomfortable" and has [experienced] weakness.

Manufacturer Narrative

Supplement #1 - medwatch sent to fda on 06/07/2016.This additional event of dehydration was reported by the patient.To date, apollo has been unable to confirm the reported events with the patient's physician.Device labeling addresses possible outcome of dehydration as follows: ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.

Event Description

Additional event reported as: a patient with the lap-band system was reported to be "dehydrated and not able to keep food in, the general surgeon went ahead to perform the surgery.".

• Brand Name: LAP-BAND AP STANDARD WITH ACCESS PORT I
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. captial 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: 5611707
• MDR Text Key: 43775821
• Report Number: 3006722112-2016-00095
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020183
• UDI-Public: 10811955020183
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/30/2016

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 Expiration Date: 07/29/2010
• Device Catalogue Number: B-2240
• Device Lot Number: 1635201
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/30/2016
• Initial Date FDA Received: 04/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2008
• 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: 54 YR
• Patient Weight: 69