MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED STENT GRAFT

Model Number	BA22-70/I16-30
Medical Device Problem Codes	Bent (1059); Partial Blockage (1065); Off-Label Use (1494); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Failure of Implant (1924); Stenosis (2263)
Date of Event	01/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
This patient had an afx graft placed on (b)(6) 2016 to treat aortic stenosis.Through regular follow up, an updated scan revealed that the main body graft appeared to be pinched in or narrowed a bit at the area of the stenosis.The physician elected to placed a bare metal and balloon expandable stent to open the area.The physician was pleased with the angiographic result and the patient will be monitored moving forward.No additional patient sequelae has been reported at this time.
Additional Manufacturer Narrative
Clinical evaluations was unable to find substantial evidence to support the following reported events; off label procedure, aortic stenosis, secondary endovascular procedure, and favorable patient disposition.The most likely cause of the inadequate stent graft patency is the reported off-label use (aortic stenosis and stent buckling).Procedure related harms and the final patient disposition could not be ascertained due to the lack of medical information surrounding the implant or the repair procedure.Reportedly, the patient is doing well; there have been no reports of further negative patient sequelae.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.Correction: udi#, device code: remove 3323, 3263.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7251829
• Report Number: 2031527-2018-00075
• Device Sequence Number: 13720013
• Product Code: MIH
• UDI-Device Identifier: 00818009010094
• UDI-Public: (01)00818009010094
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2018

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?: Yes
• Operator of Device: Paramedic
• Device Expiration Date: 12/10/2018
• Device Model Number: BA22-70/I16-30
• Device Lot Number: 1297632007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VELA INFRARENAL- LOT: 1264384-017; VELA INFRARENAL- LOT: 1264384-017
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR