MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA22-60/I13-40
Medical Device Problem Codes	Partial Blockage (1065); Off-Label Use (1494)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	07/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is anticipated that the device remains in the patient.If additional information pertinent to the event is obtained, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2016, the patient was initially implanted with an afx2 bifurcated stent graft.On (b)(6) 2017, a secondary procedure was performed for an unknown reason.During the secondary procedure a afx vela infrarenal was implanted.No additional event or patient information is available.
Event or Problem Description
Subsequent to the initial mrd, additional information was received.The implanting physician for the primary procedure performed on (b)(6) 2016 was dr.(b)(6).Reportedly, the patient developed a narrowing in the aorta above the afx2 graft.The secondary procedure on (b)(6) 2017, was performed by dr.(b)(6) to extend up the renals.Both procedures were performed at (b)(6) hospital.No additional event or patient information is available.
Additional Manufacturer Narrative
Based on the information received, clinical assessment determined the narrowing above the stent graft complaint is refuted rather there was a complete occlusion of the aorto-illiac artery.Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was reported to be in stable post the secondary endovascular procedure.A definitive root cause was not determined; however, the most likely cause of the occlusion was pre-existing occlusive aorto-illiac disease which was observed in implant angiogram.In addition the off-label use of stent placed in non-aneurysmal aorta.The device remains in the patient and will not be returned for evaluation.The review of manufacturing lot confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.Initial reporter name: correction.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7444341
• Report Number: 2031527-2018-00319
• Device Sequence Number: 11075812
• Product Code: MIH
• UDI-Device Identifier: 00818009015068
• UDI-Public: (01)00818009015068(17)170329
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 03/29/2017
• Device Model Number: BEA22-60/I13-40
• Device Lot Number: 1356049021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 07/25/2018
• 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: 51 YR