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

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

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: contraindications: patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system or who have exhibited pain intolerance to implanted devices.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.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.Special notice: the manufacturer of the lap-band ap® adjustable gastric banding system has designed, tested and manufactured it to be reasonably fit for its intended use.However, the lap-band ap® system is not a lifetime product and it may break or fail, in whole or in part, at any time after implantation and not withstanding the absence of any defect.Causes of partial or complete failure include, without limitation, expected or unexpected bodily reactions to the presence and position of the implanted device, rare or atypical medical complications, component failure and normal wear and tear.In addition, the lap-band ap® system may be easily damaged by improper handling or use.

Event Description

Reported as: a patient with the lap-band system was reported to have an allergic reaction.Physician had a patient with the lagb system who started having an allergic reaction of which impacted the dermal tissue on the patient's hands.[patient] tested positive for allergy to plasticizers.The patient's allergic reaction resolved after removal of the lagb system.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. captial tx hwy; bldg. 1 suite 300; austin TX 78746
• Manufacturer (Section G): ALLERGAN; global park free zone; 900 global park; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. captial tx hwy; bldg. 1 suite 300; austin, TX 78746
• MDR Report Key: 6712337
• MDR Text Key: 80016832
• Report Number: 3006722112-2017-00238
• 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
• Report Date: 06/15/2017

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 07/13/2017
• 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): Required Intervention