MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number	I20-13/C70F SA
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Obstruction of Flow (2423); Material Deformation (2976)
Health Effect - Clinical Codes	Occlusion (1984); Thrombosis (2100)
Date of Event	08/03/2018
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.
Event or Problem Description
The patient was initially treated with the afx2 abdominal aortic aneurysm stent on (b)(6) 2018.During the initial procedure, the contralateral limb did not fully deploy and appeared constrained at the bifurcation of the graft.After ballooning (pta), the stent recoiled but the flow through the graft appeared robust.The patient presented emergently one (1) month post-op with a cold leg and a thrombosed right iliac limb of the afx graft.The physician elected to treat the patient by lysis and implanting bilateral "kissing" stents on (b)(6) 2018, which successfully restored flow.The patient is doing well and there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the reported event of stent buckling of the right iliac limb.There was unsubstantial evidence to support the reported event of occlusion within the stent and ischemia of the lower leg.Device, user or procedure relatedness cannot be determined.Procedure related harms cannot be determined.The patient was reported as doing well post intervention.No contributing factors could be determined.The manufacturing lot review confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8005530
• Report Number: 2031527-2018-00809
• Device Sequence Number: 1190406
• Product Code: MIH
• UDI-Device Identifier: 00818009011442
• UDI-Public: (01)00818009011442(17)210322
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2018

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: Health Professional
• Device Expiration Date: 03/22/2021
• Device Model Number: I20-13/C70F SA
• Device Lot Number: 1823310-003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 12/13/2018
• 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: AFX-VELA SUPRARENAL: 1801885-008; AFX2-AFX2 BIFURCATED STENT GRAFT: 1728094-010; AFX-VELA SUPRARENAL: 1801885-008; AFX2-AFX2 BIFURCATED STENT GRAFT: 1728094-010
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR