MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; AFX INTRODUCER SYSTEM II

Model Number	S17-45
Medical Device Problem Codes	Partial Blockage (1065); Hole In Material (1293); Leak/Splash (1354); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Intimal Dissection (1333); Ischemia (1942); Stenosis (2263); Blood Loss (2597)
Date of Event	01/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Devices remain implanted in the patient.
Event or Problem Description
It was reported the patient had an initial procedure with two bifurcated devices and a suprarenal aortic extension.Following the implant procedure the physician identified a dissection and stenosis of the left common femoral artery (lcfa) which needed surgical repair.The intimal flap was observed covering the superficial femoral artery (sfa) as well as the profunda causing the stenosis.The physician completed an endarterectomy with cormatrix patch closure to resolve the issue.The patient is reported as well following the procedure.
Additional Manufacturer Narrative
At the completion of the investigation, based on the information received the following were confirmed; dissection (windsocked intima--superficial femoral artery), stenosis, and endarterectomy with patch.Additionally there was evidence to reasonably support the following observations; non-endologix iliac stent, endoleak type iiib, acute blood loss, and ischemia.Clinical found evidence to reasonably suggest the following contributing factors to the reported event; delivery system into moderate/severe calcified vessel, intimal flap covered ostium, stenosis repair of itimal flap, and the additional surgical procedure.The clinical assessment findings within this investigation were a reflection of the evaluation performed by clinical department.The review of manufacturing lot confirmed all devices met specifications prior to release.Device was not returned, therefore, sample evaluation was not completed.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX
• Common Device Name: AFX INTRODUCER SYSTEM II
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6461903
• Report Number: 2031527-2017-00134
• Device Sequence Number: 10881756
• Product Code: MIH
• UDI-Device Identifier: 00818009011381
• UDI-Public: (01)00818009011381(17)180623
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: PO40002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2017

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: Health Professional
• Device Expiration Date: 06/23/2018
• Device Model Number: S17-45
• Device Lot Number: 1318869-002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: 03/06/2017
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 07/12/2017
• 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: BIFURCATED STENT GRAFT - (B)(4); BIFURCATED STENT GRAFT - (B)(4); VELA SUPRARENAL - (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR