MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAGB SYSTEM 10CM; ADJUSTABLE GASTRIC BAND

Model Number B-20220

Device Problem Device Slipped (1584)

Patient Problems Adhesion(s) (1695); Pain (1994); Vomiting (2144); Complaint, Ill-Defined (2331); Malaise (2359); Depression (2361); Obstruction/Occlusion (2422); Patient Problem/Medical Problem (2688)

Event Date 02/01/2011

Event Type  Injury  

Manufacturer Narrative

Taper unknown.These events were reported by the patient.To date, apollo has been unable to confirm the reported events with the patient's physician.To date, apollo has not received the device.If returned, visual examination may confirm the taper type associated with this event.Device labeling addresses the reported event as follows: precautions: it is the responsibility of the surgeon to advise the patient of the known risks and complications associated with the surgical procedure and implant.Revision procedures may require the existing staple line to be partially disrupted to avoid having a second point of obstruction below the band.As with any revision procedure, the possibility of complications such as erosion and infection is increased.Any damage to the stomach during the procedure may result in peritonitis and death or in late erosion of the device into the gi tract.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.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.Obstruction of stomas has been reported as both an early and a late complication of this procedure.This can be caused by edema, food, improper initial calibration, band slippage, pouch torsion or patient non-compliance regarding choice and chewing of food.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.Other adverse events considered related to the lap-band® system that occurred in fewer than 1% of subjects included: esophagitis, gastritis, hiatal hernia, pancreatitis, abdominal pain, hernia, incisional infection, infection, redundant skin, dehydration, gi perforation, diarrhea, abnormal stools, constipation, flatulence, dyspepsia, eructation, cardiospasm, hematemesis, asthenia, fever, chest pain, incision pain, contact dermatitis, abnormal healing, edema, paresthesia, dysmenorrhea, hypochromic anemia, band leak, cholecystitis, esophageal dysmotility, esophageal ulcer, esophagitis, port displacement, port site pain, spleen injury and wound infection.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.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.

Event Description

Reported as: the patient had their entire lap-band system removed as patient "had many various illness shortly after it was implanted.In constant pain, 24/7.Was told repeatedly it was not the band.I finally convinced doctors that what [patient] was going through was the band.I have high liver levels and am hoping that they'll go down now that the band is gone.I have had pain in my rib area, sternum through my back, collar bone, shoulder and down my left arm.Hospitalized twice for possible heart issues and my heart's fine.Was heaving, throwing up, fatigued, liver problems, ear nose and throat problems.Local doctors made me feel as though i was crazy.I went through depression, brain fog, my sight has been affected.I had all over joint and muscle pain that lasted 18 months.Couldn't raise my arms above my head.Tested out the wazoo and no arthritis.My stomach came up through the band and caused blockage and severe pain.So much scar tissue also.".

• Brand Name: LAGB SYSTEM 10CM
• 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
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795100
• MDR Report Key: 7550763
• MDR Text Key: 109453621
• Report Number: 3006722112-2018-00132
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020169
• UDI-Public: 10811955020169
• 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
• Report Date: 04/30/2018

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: Physician
• Device Expiration Date: 10/24/2009
• Device Model Number: B-20220
• Device Catalogue Number: B-20220
• Device Lot Number: 1505873
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2007
• 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
• Treatment: IBUPROFEN; LISINOPRIL TO; ZOLOFT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 95