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

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Unknown taper.This event was captured in a literature article published in september, 2018.The reporter of the event was asked if the product was available for analysis and to provide device and patient information.To date, apollo has not been able to confirm device information from the reporter.Without device or device serial, the taper type is unknown.Further information has been requested of the reporter regarding: implant date, explant date, date of occurrence, and additional patient information.If returned, visual examination may confirm or determine another taper type associated with this event.Related medwatches sent for this article are: 3006722112-2018-00284, 3006722112-2018-00285, 3006722112-2018-00286, 3006722112-2018-00287, 3006722112-2018-00288, and 3006722112-2018-00289.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.If fluid has been added, it is important to establish that the stoma is not too small before discharge.Care must be taken to not add too much saline, thereby closing the stoma.Check the adjustment by having the patient drink water.If the patient is unable to swallow, remove some fluid from the port, then re-check.A physician familiar with the adjustment procedure must be available for several days post-adjustment to deflate the band in case of an obstruction.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.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

Literature review performed: "weight loss outcomes of laparoscopic adjustable gastric band with plication: a single center experience of 66 patients with 18-month follow-up" daniel cottam et al.Obesity surgery 2018.A lap-band patient experienced long term complication of odynophagia.The band was removed within 12-54 months after implant surgery.

• 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
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795100
• MDR Report Key: 8047988
• MDR Text Key: 126442866
• Report Number: 3006722112-2018-00290
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2018

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: 10/08/2018
• Initial Date FDA Received: 11/07/2018
• 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