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

Model Number	A28-28/C75V
Medical Device Problem Codes	Partial Blockage (1065); Occlusion Within Device (1423)
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994); Thrombosis (2100)
Date of Event	10/02/2017
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; thrombosis of infrarenal and main body stents(reported in report#: 2031527-2017-00550).The most likely cause of the inadequate stent graft patency and occlusion of both the suprarenal cuff and main body stents could not be determined.However, a likely contributing factor was a systemic prothrombic preexisting condition that was exacerbated by the discontinuation of a prescribed anticoagulant.Associated clinical harms include: aortic and iliac occlusion, ischemia and a secondary endovascular procedure.Patient was discharged home on the fourth post-operative day.The review of manufacturing lot confirmed all devices met specifications prior to release.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
The patient was initially treated with afx.Approximately, three (3) months post implant, the patient presented emergently with cold legs.Upon ct and angio it was discovered the graft was filled with a clot below the renals to the hypogastric arteries.The patient underwent intervention day of emergent presentation.The physician used fogerty balloon catheter's and lined the iliacs with lifestream covered stents.The final angio showed good flow throughout the graft.The patient is reported as well post intervention.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7162563
• Report Number: 2031527-2018-00001
• Device Sequence Number: 13471082
• Product Code: MIH
• UDI-Device Identifier: 00818009013514
• UDI-Public: (01)00818009013514(17)191128
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/20/2017

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: 11/28/2019
• Device Model Number: A28-28/C75V
• Device Lot Number: 1621209009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 01/03/2018
• 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: 77 YR