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

Catalog Number B-2245

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Slipped (1584)

Patient Problems Inflammation (1932); Regurgitation (2259); Patient Problem/Medical Problem (2688)

Event Date 01/06/2011

Event Type  Injury  

Manufacturer Narrative

Unknown taper.This event was reported by the patient.To date, apollo has been unable to confirm the reported events with the patient's physician.The device will not be returned for analysis.Further information regarding device catalog and serial number have been requested, to date no additional information has been received by apollo.Without the device or serial number/catalog, the connector type associated with this event could not be determined.Device labeling addresses possible outcomes of band restriction issue, band slip, reflux, adhesions, irritation/inflammation 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.Band slippage and/or pouch dilatation can occur.Gastroesophageal reflux, nausea and/or vomiting with early or minor slippage may be successfully resolved by band deflation in some cases.More serious slippages may require surgery to reposition and/or remove the band.Immediate re-operation to remove the band is indicated if there is total stoma-outlet obstruction that does not respond to band deflation or if there is abdominal pain.Gastric banding done as a revision procedure has a greater risk of complications.Prior abdominal surgery is commonly associated with adhesions involving the stomach.In the us pivotal study of severely obese adults, 42% of the subjects undergoing revision surgery were reported to have adhesions involving the stomach.Care and time must be taken to adequately release the adhesions to provide access, exposure and mobilization of the stomach for a revision procedure.Nausea and vomiting may occur, particularly in the first few days after surgery and when the patient eats more than recommended.Other adverse events considered related to the lap-band system that occurred in fewer than 2% of study patients included: diarrhea (n=2), gastric pouch dilatation (n=2), gastritis (n=2), esophageal dilatation (n=2), syncope (n=2), seroma (n=2).Other events reported to occur in only one patient per event included; abdominal discomfort, alopecia, anemia, arthralgia, decrease blood folate, flatulence, gastrointestinal motility disorder, bronchitis, chills, implant site infection, implant site irritation, implant site hemorrhage, night sweats, hypotrichosis, headache, nail infection, pyrexia, skin irritation, esophageal obstruction, esophageal spasm, postoperative infection, urinary tract infection, muscle spasms, depression, back pain, and hypertension.

Event Description

Reported as: a patient with the lap-band system was reported to have a "failed lap-band." patient reports that they were never advised to the extensive scar tissue, thinning of the stomach or damage to the esophagus that the patient could experience.The patient "never had proper restriction" and after several months the doctor identified the band had slipped."the band slipped several times and then i had it revised." after revision surgery the patient continued to struggle with proper restriction and had the device removed.Patient now struggles with acid reflux and had "a large amount of scar tissue" removed to get the port out.Patient is currently waiting for swelling to go down so the doctor can determine if additional damage has been done.Additional information provided by the patient does not know if she has damage to the esophagus.And is waiting to be scoped to verify if any damage was done to either the esophagus or stomach.Patient now suffers from chronic acid reflux and has had to take medication daily to manage it and the esophagitis.The patient's lap-band system was explanted.

• Brand Name: LAP-BAND AP LARGE 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: 5658056
• MDR Text Key: 45276015
• Report Number: 3006722112-2016-00119
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020190
• UDI-Public: 10811955020190
• 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
• Type of Report: Initial
• Report Date: 04/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: B-2245
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2016
• 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
• Patient Age: 43 YR
• Patient Weight: 135