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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Adhesion(s) (1695); Erosion (1750); Hemorrhage/Bleeding (1888); Pain (1994); Seroma (2069); Vomiting (2144); Ulcer (2274)

Event Date 10/15/2014

Event Type  Injury  

Manufacturer Narrative

Unknown taper.Medwatch sent to the fda on 11/01/2016.The reporter of the event was asked to return the product for analysis, and to indicate product serial number.To date, neither the device nor any further device information has been received by apollo.Without device or device serial, the taper type is unknown.If returned, visual examination may determine the connector type associated with this event.This event was reported by the patient.To date, apollo has been unable to confirm the reported events with the patient's physician.Device labeling addresses the reported event as follows: precautions: 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.Over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation.Anti-inflammatory agents, such as aspirin and non-steroidal anti-inflammatory drugs (nsaids), may irritate the stomach and should be used with caution.The use of such medications may be associated with an increased risk of erosion.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.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 (b)(6) 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.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.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.

Event Description

Reported as: a patient with the lap-band system was reported to have the device "eroded in my stomach," which made her "bleed out and almost made her die." patient stated that she could see "a red streak going up her stomach." she could see the cord going up her stomach.The doctor removed the cord and the port but left the band.The patient then started to have a seroma, chronic pain, vomiting and fainted.She went to the hospital and had a low hemoglobin.The doctor removed the device that day.Patient has a scar where the band was that is approximately 6cm long that continues to bleed.Patient continues to have pain and vomiting.

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.Device labeling addresses the reported event of ulcers as follows: adverse events: ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.

Event Description

Additional information: since the lap-band was removed the patient was diagnosed with gastroparesis.Patient noted that because the ulcers never healed, it was recommended to have a partial gastrectomy.The patient ended up having a total gastrectomy.Patient reported spent a "week at [the hospital] and just got out." half of stomach had ulcers and other half was fused to diaphragm.The physician's were hoping there was some tissue to save, but now patient's on a feeding tube with no stomach.

• Brand Name: LAP-BAND SYSTEM
• 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, ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. captial tx hwy; bldg. 1 suite 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 6071208
• MDR Text Key: 58925362
• Report Number: 3006722112-2016-00317
• Device Sequence Number: 1
• Product Code: LTI
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2017

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?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2016
• Initial Date FDA Received: 11/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2017
• 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): Hospitalization; Required Intervention; Disability
• Patient Age: 44 YR
• Patient Weight: 95