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

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Irritation (1941)

Event Type  Injury  

Manufacturer Narrative

Unknown taper.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.Device labeling addresses the reported event as follows: 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.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 the lap-band system was reported to have an upper endoscopy which revealed "gastritis, distal esophagitis." device was removed.

Manufacturer Narrative

Taper ii.Supplement #1 - medwatch sent to fda on 29-mar-2018.Device evaluation summary: the device was returned to apollo for analysis, and visual examination confirmed the connecter type as taper ii.The lap-band, access port i, taper ii and a piece of band tubing, approximately 11.5 inches in length were all returned.An opening was noted on the port tubing, approximately 1.0 inch away from the taper tubing junction.Scratches were noted on the port housing and port holes.Needle marks were noted on the port septum.The band was noted to be separated approximately 1.0 inch from the buckle.The buckle was observed to be partially separated.The band tubing was noted to separated approximately 1.2 inches from the tubing collar/junction.The port tubing was noted to be separated approximately 1.25 inches from the stainless steel connector.A fill inspection test was performed, and no blockage was noted when colored di water was passed through the port septum, and also through the port tubing.An air leak test was not feasible, as the band was cut in half, near the buckle.Under microscopic analysis, both ends of the separated band, the buckle, both ends of the band tubing, and both ends of the port tubing all had striated edges, consistent with surgical ends cut to remove the device.An unidentified opening was observed on the port tubing, approximately 1.0 inch from the taper tubing junction.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital tx hwy; bldg. 1 suite 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 of texas hwy; bldg 1, ste. 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 7004729
• MDR Text Key: 91185334
• Report Number: 3006722112-2017-00363
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 03/07/2018
• Supplement Dates FDA Received: 03/29/2018
• 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): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 92