MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C80-O20 V
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.Device iteration is afx with duraply.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent.During the initial procedure and after the suprarenal afx device was deployed, the graft moved upward (encroaching on the left renal) when the delivery system was removed.The physician attempted to pull the graft down with a coda balloon but was unsuccessful.A wire was then advanced into the left renal and the delivery system was successfully removed.No damage was caused to either device during the procedure.The final result looked good and the renal was receiving sufficient blood supply.The patient is reportedly doing well.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was unsubstantial evidence to support the reported displacement of the proximal extension after deployment during withdrawal of the delivery system.The partial coverage of the left renal artery with left renal artery stent placement is confirmed.Device, user, procedure, or anatomy relatedness of this event could not be determined; angiogram did not have imaging of the suprarenal device position prior to deployment and the resultant placement with respect to the renal arteries.The procedure-related harm identified was implantation of a left renal stent.The final patient status was discharged home on the third post-operative day in stable condition.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.
Event or Problem Description
Additional information received confirming that the physician elected to implant an abbott (non-endologix) 6x19 bare stent into the left-side renal to treat the displaced afx vela suprarenal; the bare stent was placed during the initial implant procedure.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8642097
• Report Number: 2031527-2019-00255
• Device Sequence Number: 11263907
• Product Code: MIH
• UDI-Device Identifier: 00818009013606
• UDI-Public: (01)00818009013606(17)200928
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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: 09/28/2020
• Device Model Number: A34-34/C80-O20 V
• Device Lot Number: 1744718-024
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 07/30/2019
• 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: AFX INTRODUCER SYSTEM II: 1967877-034; AFX-VELA SUPRARENAL:1744718-024; AFX2 BIFURCATED STENT GRAFT:2007989R-003; AFX-VELA SUPRARENAL: 1744718-024; AFX2 BIFURCATED STENT GRAFT: 2007989R-003
• Outcome Attributed to Adverse Event: Other; Required Intervention