MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A28-28/C75-O20V
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	02/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A clinical evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging; requests were made and denied response was received.As such, event determination, off-label conditions, related patient harms, and patient disposition could not be independently assessed.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
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent.One (1) day post initial procedure, the physician noted that the patient had no flow to the renal artery, no urine output, and high creatinine levels.An ultrasound showed that the renal artery was covered; the physician believes that this was a result of the x-ray technician inadvertently moving the x-ray tube during the initial procedure, which may have changed the landing mark of the stent graft.The physician elected to treat the patient by performing a bypass procedure on (b)(6) 2019.The patient was stable when leaving the operating room.There have been no additional patient sequelae reported.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8400966
• Report Number: 2031527-2019-00112
• Device Sequence Number: 16651508
• Product Code: MIH
• UDI-Device Identifier: 00818009013583
• UDI-Public: (01)00818009013583(17)210501
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2019

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: 05/01/2021
• Device Model Number: A28-28/C75-O20V
• Device Lot Number: 1930793-003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 03/07/2019
• 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: AFX2 BIFURCATED STENT GRAFT: 1948972-006
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR