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

Model Number	BEA22-40/I13-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation.If additional information pertinent to the event is obtained, a follow-up report will be submitted.
Event or Problem Description
The primary procedure was performed on (b)(6) 2016, the patient was implanted with an afx bifurcated stent and an ovation iliac limb extension on the right side.Patient presented at physician's office complaining of left leg pain.As the patient was reported to have extensive peripheral vascular disease.The physician elected to treat the contra side of the previously implanted edologix limb in order to treat the disease progression.There was no reported device issue of previously implanted stents.On (b)(6) 2016, an additional ovation iliac limb extension was implanted.The patient was reported to be pain free and doing great.There has been no patient sequelae reported at this time.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92681
• MDR Report Key: 7442294
• Report Number: 2031527-2018-00198
• Device Sequence Number: 1963545
• Product Code: MIH
• UDI-Device Identifier: 00818009015075
• UDI-Public: (01)00818009015075(17)170512
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2016

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: Physician
• Device Expiration Date: 05/12/2017
• Device Model Number: BEA22-40/I13-40
• Device Lot Number: 1488577018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2016
• Initial Report FDA Received Date: 04/18/2018
• 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: OVATION PRIME ILIAC LIMB: LN FS040715-26
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR