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

Model Number	BEA25-80/I13-40
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984); Stenosis (2263)
Date of Event	02/01/2018
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.
Event or Problem Description
On (b)(4) 2018, endologix was made aware by a rep on a recent visit to a physician at (b)(6).Based on ctas, the patient's two (2) physicians decided that a secondary procedure was needed to correct the middle narrowing of the bifurcated graft, which was placed on (b)(6) 2017.The secondary procedure (ivus) was performed on (b)(6) 2018 with a non-endologix stent.The procedure was successful with the expansion of the device in the narrowed segment.The patient's condition was stable post-op surgery.
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.Clinical was able to confirm the secondary procedure for 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 mid aortic stenosis was the pre-existing, off label aorto-iliac stenosis.There were no procedure related harms, and the patient was discharged in good condition on the first post operative day.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and will not be returned and no evaluation will be completed.These types of events will be monitored and trended as part of the quality system.(b)(4).

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7299124
• Report Number: 2031527-2018-00124
• Device Sequence Number: 19331310
• Product Code: MIH
• UDI-Device Identifier: 00818009014788
• UDI-Public: (01)00818009014788(17)180228
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/01/2018

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: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: BEA25-80/I13-40
• Device Lot Number: 1662095006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 06/04/2018
• 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: VELA SUPRARENAL, LOT 1743667001
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR