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

Model Number B-2220

Device Problem Fluid/Blood Leak (1250)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Inflammation (1932); Nausea (1970); Pleural Effusion (2010); Scar Tissue (2060); Vomiting (2144); Hematuria (2558); Dysuria (2684); Patient Problem/Medical Problem (2688)

Event Date 12/07/2012

Event Type  malfunction  

Manufacturer Narrative

Taper ii.Device evaluation summary: a visual examination was performed on the received lap-band with access port i, taper type ii.The band was separated from the port at the taper tubing junction.Red particulate matter was observed on the port, port septum, and port base.The band was separated near the belt.Red particulate matter was also noted on the outer surfaces of the ring, belt, buckle, and buckle strap, as well as on the inner and outer surface of the band shell.A portion of the buckle strap was noted to be missing.A port leak test was performed, and no leakage was noted.A fill inspection test was performed, and no blockage was noted when colored di water was passed through the port septum and tubing.An air leak test was performed, and the band was leaking from the ring/shell where the band had been separated near the belt.Under microscopic analysis, the end of the port tubing was noted to have striations, consistent with a surgical end cut.The end of the band tubing was also observed to be surgically cut, as the edges were noted to be striated.The lap-band ring and shell were noted to have striations where the band was separated near the belt, consistent with a surgical end cut to remove the device.The buckle strap was noted to be partially separated.The edges of the buckle strap were observed to be striated and consistent with surgical damage from device removal activities.A portion of the end of the buckle strap, approximately 0.3 inches in length, was missing.The edge of the buckle strap where the missing material was identified was noted to be striated and consistent with damage from a surgical tool.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.As with gastroplasty surgeries, particular care must be taken during dissection and during implantation of the device to avoid damage to the gastrointestinal tract.Any damage to the stomach during the procedure may result in erosion of the device into the gi tract.During insertion of the calibration tube, care must be taken to prevent perforation of the esophagus or stomach.Care must be taken during band adjustment to avoid puncturing the tubing that connects the access port and band, as this will cause leakage and deflation of the inflatable section.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.Do not push the tip of any instrument against the stomach wall or use excessive electrocautery.Stomach perforation or damage may result.Stomach perforation may result in peritonitis and death.When adjusting band volume, use of an inappropriate needle may cause access port leakage and require re-operation to replace the port.Use only lap-band ap® system access port needles.Do not use standard hypodermic needles, as these may cause leaks.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.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.Perforation of the stomach can occur.Death can also occur.Specific complications of laparoscopic surgery can include spleen damage (sometimes requiring splenectomy) or liver damage, bleeding from major blood vessels, lung problems, thrombosis, and rupture of the wound.Ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.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.Unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.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.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: a patient with lap-band system had presented to emergency room (er) due to abdominal pain "cramping" along with nausea and diarrhea.X-ray was performed and er physician suspected small right pleural effusion and lap-band in place with no device adverse feature.Five years later patient had presented to emergency department (ed) again 3 days after abdominal pain started with pertinent negatives: diarrhea, dysuria, hematuria, and vomiting.Patient reported their lap-band system was explanted due to "device complications.Inflamed inside lining of the stomach, hole in the band, it was broken and causing bowel issues, being sick a lot.Going to bathroom hurt a lot between my legs when i pee.Took pain medication but did not help.Developed "scar tissues that were pretty big" in the stomach, the band made it "hard to go to the bathroom", and was "bleeding from [their] behind"." physician confirmed through ct scan and pelvis without contrast and x-ray "lap-band tubing disconnected from the port with the tip of the tubing in left lower pelvis", but noted patient's severe pelvic pain was not related to the tubing.Physician removed the entire lap-band system as the patient has not lost weight with the device.

• 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: 6942635
• MDR Text Key: 90163763
• Report Number: 3006722112-2017-00334
• 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,health professional
• Type of Report: Initial
• Report Date: 09/13/2017

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: B-2220
• Device Catalogue Number: B-2220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 91