MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX2; BIFURCATED

Model Number	BEA22-40/I13-40, AFX2
Medical Device Problem Codes	Difficult To Position (1467); Activation, Positioning or Separation Problem (2906); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984)
Date of Event	05/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device remains implanted in the patient.
Event or Problem Description
It was reported that the patient had initially been implanted with a competitor device at an unknown date.Subsequently, due to occlusive disease, the patient was scheduled for an implant of a bifurcated device on (b)(6) 2016.During implant, the physician encountered difficulty with deployment due to the competitor stent becoming twisted and causing a left limb occlusion of the bifurcated device.Physician corrected the issue by performing an aui fem-fem bypass.The patient came out with satisfactory results.

• Brand Name: AFX2
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5697877
• Report Number: 2031527-2016-00265
• Device Sequence Number: 16190563
• Product Code: MIH
• UDI-Device Identifier: 00818009015075
• UDI-Public: (01)00818009015075(17)170408
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: PO40002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2016

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2017
• Device Model Number: BEA22-40/I13-40, AFX2
• Device Lot Number: 1356110-005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2016
• Initial Report FDA Received Date: 06/03/2016
• 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: 60 YR