MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND AP STANDARD WITH ACCESS PORT I; ADJUSTABLE GASTRIC BAND

Model Number B-2240

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

Patient Problems Dysphagia/ Odynophagia (1815); Unspecified Infection (1930); Seroma (2069); Regurgitation (2259)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

Unknown taper.Medwatch sent to the fda on 08/31/2016.The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.If returned, visual examination may determine the taper type associated with this event.Further information has been requested of the initial reporter.To date, no additional information has been received by apollo.Device labeling addresses the event as follows: adverse events: infection can occur in the immediate post-operative period or years after insertion of the device.In the presence of infection or contamination, removal of the device is indicated.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.How supplied: lap-band system boxes should be stored in a clean, dry location (standard hospital supply storage).The lap-band system has a two-year shelf life.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 a "port site infection and seroma." device has been explanted.

Manufacturer Narrative

Device labeling addresses the reported events of dysphagia and reflux 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.

Event Description

Reported as: a patient with the lap-band system was reported to have additional events of dysphagia and gerd.

Manufacturer Narrative

Supplement #2 - medwatch sent to the fda on 09-aug-2017.Device evaluation summary: the device was returned to apollo for analysis, and visual examination confirmed the connector type as taper ii.Brown discoloration was observed on the port septum, port tubing, band ring, shell, and buckle.White particles were observed on the outer surface of the shell.Needle marks were observed on the port septum.Scratches were observed on the port, near the port holes.A fill inspection test was performed and noted no blockage.A leak test was performed and no leakage was observed.Under microscopic analysis, the band tubing and port tubing were noted to have a surgical end cut, consistent with device removal.

• Brand Name: LAP-BAND AP STANDARD WITH ACCESS PORT I
• 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: 5918303
• MDR Text Key: 53612119
• Report Number: 3006722112-2016-00264
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020183
• UDI-Public: 10811955020183
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2017

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: Health Professional
• Device Expiration Date: 01/04/2013
• Device Model Number: B-2240
• Device Catalogue Number: B-2240
• Device Lot Number: 2061685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2016
• Initial Date FDA Received: 08/31/2016
• Supplement Dates Manufacturer Received: Not provided; 07/12/2017
• Supplement Dates FDA Received: 12/01/2016; 08/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2011
• 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: CHANTEX
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 72