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

Model Number	B-2265
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Sepsis (2067)
Date of Event	07/01/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Taper ii : the reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Based on the serial number provided, the connecter type is assumed to be a taper ii.Further information has been requested of the initial reporter regarding further clarification on the reported event, the explanting physician, and relevant patient history.To date, no additional information has been received by apollo.Device labeling addresses possible outcomes of pain and sepsis as follows: warnings: patients must be carefully counseled on the need to report all vomiting, abdominal pain or other gastrointestinal or nutritional issues as these symptoms may indicate a condition not related to the lap-band® system.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.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.
Event or Problem Description
Reported as: a patient with the lap-band system was reported to have "had abdominal pain, presented to hospital and found to have free fluid and sepsis, band explanted.Patient presented to hospital and was taken to the operating room.Patient wants the band replaced.".

• Brand Name: LAP-BAND AP LARGE WITH ACCESS PORT II
• Common Device Name: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. captial of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 5555132
• Report Number: 3006722112-2016-00072
• Device Sequence Number: 875730
• Product Code: LTI
• UDI-Device Identifier: 10811955020237
• UDI-Public: 10811955020237
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2016

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
• Operator of Device: Physician
• Device Expiration Date: 02/14/2015
• Device Model Number: B-2265
• Device Catalogue Number: B-2265
• Device Lot Number: 2405457
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2016
• Initial Report FDA Received Date: 04/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR