MAUDE Adverse Event Report: ENDOLOGIX AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA25-110/I16-30
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Failure of Implant (1924); Ischemia (1942)
Date of Event	05/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
An afx2 bifurcated stent graft was implanted with a vela suprarenal cuff to treat an abdominal aortic aneurysm.Following completion of the endovascular repair, the patient's right pedal pulse was noted to be diminished.The patient underwent exploration of the right femoral artery, which revealed a dissection flap within the artery, which obstructed arterial flow.A re-intervention was performed on the date of the stent graft implantation, where a right femoral artery endarterectomy was performed and closed using a bovine pericardial patch.Following the re-intervention, the patient's right pedal pulse was restored to normal.The patient was discharged the day following the index procedure.As the date of this report, thave been no additional patient sequelae reported and the patient will continue to be monitored.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6665120
• Report Number: 2031527-2017-00325
• Device Sequence Number: 11255947
• Product Code: MIH
• UDI-Device Identifier: 00818009014856
• UDI-Public: (01)00818009014856(17)180301
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2017

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: 03/01/2018
• Device Model Number: BEA25-110/I16-30
• Device Lot Number: 1662237001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 06/23/2017
• 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: 82 YR