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

Model Number	BEA22-40/I13-40
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984)
Date of Event	12/10/2017
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
The patient was initially implanted with a bifurcated stent to treat occlusive disease.It was reported a follow up computed tomography (ct) showed the patient had an occlusion in the main body stent.The physician elected to complete an aui fem-fem bypass to restore patency.The patient is reported to be well post procedure.There have been no additional adverse events reported for this patient.
Additional Manufacturer Narrative
Based on the information received at the completion of the clinical evaluation, there were reported evidence that supported the following case event.A re-intervention was done on (b)(6) 2017 to correct the occlusion.Patient was doing well post op.Clinical was able to confirm the aorto-bi-iliac occlusion with preexisting aortic stenosis.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the aorto-bi-iliac occlusion was the preexisting occlusive disease and intentional user error due to the off label aorto-iliac anatomy.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and will not returned and no evaluation will be completed.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7184767
• Report Number: 2031527-2018-00031
• Device Sequence Number: 1044236
• Product Code: MIH
• UDI-Device Identifier: 00818009015075
• UDI-Public: (01)00818009015075(17)180512
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 12/13/2017

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?: Yes
• Operator of Device: No Information
• Device Expiration Date: 05/12/2018
• Device Model Number: BEA22-40/I13-40
• Device Lot Number: 1686286-010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 03/19/2018
• 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: 64 YR