MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; VELA SUPRARENAL

Model Number	A28-28/C75-O20V
Medical Device Problem Codes	Partial Blockage (1065); Occlusion Within Device (1423)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984); Thrombus (2101); Stenosis (2263); Claudication (2550)
Date of Event	11/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events; left iliac limb occlusion of the main body(reported in a separated report), circumferential thrombus in suprarenal cuff and main body (inadequate stent graft patency), and right to left femoral-femoral bypass.Additionally there was evidence to reasonably support the following observations; right iliac limb stenosis, non-endologix stent placed, and left limb ischemia.The most likely cause of the inadequate stent graft patency of the right iliac limb and the occlusion of the left iliac limb was related to the small aortic bifurcation and calcifications at the bifurcation and proximal common iliac arteries.The most likely cause of the inadequate stent graft patency of the suprarenal cuff and main body could not be determined.Associated clinical harms included: ischemia, claudication, stenosis, thrombus, occlusion, secondary endovascular procedure (right iliac limb non-endologix stent placement), and additional surgical procedure (fem-fem bypass).The final patient disposition was discharged home on post-operative day one in good condition.Devices remain implanted in the patient and were not returned, no evaluation completed.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.
Event or Problem Description
Patient presented symptomatically and it was discovered that the patient had a left iliac limb occlusion and abundant thrombus inside the graft.Patient reported to be in good condition.During clinical evaluation that was completed on (b)(6) 2018, it was confirmed through medical records that the patient had a re-intervention on (b)(6) 2017 where a non-endologix stent was placed.Patient was discharged home on (b)(6) 2017.No additional patient sequalae has been reported.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7275500
• Report Number: 2031527-2018-00099
• Device Sequence Number: 10793761
• Product Code: MIH
• UDI-Device Identifier: 00818009013583
• UDI-Public: (01)00818009013583(17)200315
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 02/12/2018

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: 03/15/2020
• Device Model Number: A28-28/C75-O20V
• Device Lot Number: 1666963-004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 02/15/2018
• 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: 70 YR