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

Model Number	BEA25-80/I13-40, AFX2
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	07/15/2016
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.Devices remain implanted in the patient.
Event or Problem Description
It was reported the patient had an initial procedure on (b)(6) 2016 with a bifurcated and 3 ovation extenders.During the procedure, wire access was lost and pushed back up after bifurcated device placement, inadvertently placing the wire behind the graft.The physician proceeded to place a limb extension behind the bifurcated limb, effectively shutting off flow to the right common and external iliac.They were unable to correct the issue so due to the occluded iliac, the physician had to convert to a fem-fem bypass.Patient is in stable condition.

• Brand Name: AFX2
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5873726
• Report Number: 2031527-2016-00397
• Device Sequence Number: 1366939
• Product Code: MIH
• UDI-Device Identifier: 00818009014788
• UDI-Public: (01)00818009014788(17)170217
• 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): 07/15/2016

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: 02/17/2017
• Device Model Number: BEA25-80/I13-40, AFX2
• Device Lot Number: 1355589-025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2016
• Initial Report FDA Received Date: 08/12/2016
• 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: 63 YR