MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND SYSTEM; ADJUSTABLE GASTRIC BAND

Device Problem Device Slipped (1584)

Patient Problems Adhesion(s) (1695); Pain (1994)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Unknown taper.The reporter of the event was asked if the product was available for analysis and to provide device information.To date, apollo has not been able to confirm device information from the reporter and the device manufacturer is unknown.Further information has been requested of the reporter regarding: implant date, explant date, date of occurrence, and additional patient information.The reporter of the event noted no additional information can be provided.The patient's previous band removal will be captured under mdr 3006722112 2018 00253.A review of the device labeling noted the following: description: surgeons planning laparoscopic placement must have extensive advanced laparoscopic experience, i.E., fundoplications as well as previous experience in treating obese patients, and have the staff and commitment to comply with the long-term follow-up requirements of obesity procedures.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.It is the responsibility of the surgeon to advise the patient of the dietary restrictions that follow this procedure and to provide diet and behavior modification support.Failure to adhere to the dietary restrictions may result in obstruction and/or failure to lose weight.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.Esophageal distension or dilatation has been infrequently reported.This is most likely a consequence of incorrect band placement, over-restriction or stoma obstruction.It can also be due to excessive vomiting or patient noncompliance, and may be more likely in cases of pre-existing esophageal dysmotility.Deflation of the band is recommended if esophageal dilatation develops.A revision procedure may be necessary to reposition or remove the band if deflation does not resolve the dilatation.Slippage and/or pouch dilatation of the band can occur.Gastroesophageal reflux, nausea and/or vomiting with early or minor slippage may be in some cases successfully resolved by band deflation.More serious slippages may require band repositioning and/or removal.If there is total stoma outlet obstruction that does not respond to band deflation, or if there is abdominal pain, then immediate re-operation to remove the band is indicated.Procedure basics: as with other surgical decisions, it is the surgeon's responsibility to judge his or her skill and experience as a well as the procedure best suited to the patient's needs.Warnings: patients should be advised that the lap-band ap® system is a long-term implant.Explant 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

Literature review performed: "retained foreign body after adjustable gastric band removal: a case series." cattanach d, et al.Obes surg.2017 dec;27(12):3337-3340.Case report 1: at a ten year follow up, patient was found to have "oesophageal dilatation associated with chronic gastric band slippage." the patient's band was completely deflated and remained implanted for another eighteen months."as a result of significant weight gain, the decision was made to proceed to band removal." laparoscopic removal of the band was difficult and associated with extensive adhesiolysis.At post operative review, patient complained of umbilical and right lower quadrant abdominal pain.The pain was attributed to a right inguinal hernia.Three months later the patient presented with abdominal and pelvic pain.A ct scan was taken and a "length of free gastric band tubing in her pelvis was noted." patient proceeded to theatre where a 7cm length of band tubing was removed.Although the manufacturer of the device is unknown, it is apollo's approach to compliance to resolve all doubt in favor of reporting.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital 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, ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 7948634
• MDR Text Key: 123192905
• Report Number: 3006722112-2018-00254
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2018

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 10/09/2018
• 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: 40 YR