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

Catalog Number	B-2260
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Taper ii medwatch sent to fda on 05/27/2016.Further information has been requested of the initial reporter regarding the implant date.To date, no additional information has been received by apollo.Device evaluation summary: the device was returned to apollo for analysis, and visual examination confirmed the connector type as taper ii.Visual inspection noted the port taper tubing to be discolored, and it was observed to be yellowish in color.Brown particles were observed on the port housing.Of the port hole was damaged, with pulled material present.Scratches/non-penetrating nicks were noted on the port septum.Fluid was observed in the septum.A leak test was performed, and the port was leaking from the base.A fill inspection test was performed, and no blockage or resistance to flow was noted.Under microscopic analysis needle marks were observed in the port septum.Device labeling addresses possible outcome of port leak 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.Unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.
Event or Problem Description
Reported as: a patient with the lap-band system was reported to "port had a leak." the patient had their lap-band port removed and replaced.

• Brand Name: LAP-BAND AP STANDARD 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: 5686002
• Report Number: 3006722112-2016-00139
• Device Sequence Number: 214442
• Product Code: LTI
• UDI-Device Identifier: 10811955020220
• UDI-Public: 10811955020220
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 12/06/2015
• Device Catalogue Number: B-2260
• Device Lot Number: 2533217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2016
• Initial Report FDA Received Date: 05/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 111