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

Model Number	BEA22-80/I16-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aortic Dissection (2491)
Date of Event	04/13/2018
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)(6) 2018, endologix was made aware of a patient that had an aortic dissection distal to the original (initial) afx graft.The dissection was performed due to possible ballooning from the right common iliac after physician placed the afx, but not completely sure.Patient was symptomatic.Physician elected to add non-endologix (vbx) stents to correct the problem.The dissection was performed on the same day as the initial implant date.Rep confirmed that patient never left the hospital.Patient is reported doing fine.
Event or Problem Description
The procedure was performed on (b)(6) 2018.An afx2 bifurcated stent was implanted.After implant, a dissection occurred in the right common iliac, distal to the implant.It is possible that the dissection was due to ballooning; however, it is not clear.The physician sealed the dissection with non-endologix stents.No additional event or patient information is available.
Additional Manufacturer Narrative
Based on the information received, clinical assessment confirmed the reported aortic (right common iliac artery) dissection distal to afx2 graft.Reportedly, the dissection was possibly due to possible ballooning on right common iliac artery; however, clinical assessment was unable to confirm this.Device, user, procedure or anatomy relatedness of this complaint could not be determined based on the information shared with endologix to review.The final patient status was reported to be in stable condition.A root cause for the reported dissection was unable to be determined.The device remains in the patient and will not be returned for evaluation.The review of manufacturing lot confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.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: 7507049
• Report Number: 2031527-2018-00446
• Device Sequence Number: 233176
• Product Code: MIH
• UDI-Device Identifier: 00818009015006
• UDI-Public: (01)00818009015006(17)180801
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 08/01/2018
• Device Model Number: BEA22-80/I16-40
• Device Catalogue Number: F00820-62
• Device Lot Number: 1725964010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 07/13/2018
• 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 1752247016; VELA SUPRARENAL, LOT 1752247016
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR