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

Model Number	BA25-80/I16-55
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/23/2016
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) 2015, the patient was implanted with a bifurcated stent graft, two vela infrarenals, and two limb stent grafts (implanting physician dr.(b)(6)).On (b)(6) 2016, a secondary procedure was performed for an unknown reason and the patient was implanted with three additional limb stent grafts (implanting physician (b)(6)).No additional event or patient information is available.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7443040
• Report Number: 2031527-2018-00268
• Device Sequence Number: 1540239
• Product Code: MIH
• UDI-Device Identifier: 00818009010070
• UDI-Public: (01)00818009010070(17)180213
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2016

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: 02/13/2018
• Device Model Number: BA25-80/I16-55
• Device Lot Number: 1310342014
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2016
• Initial Report FDA Received Date: 04/19/2018
• 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 INFRARENAL (LN 1249018010); AFX VELA INFRARENAL (LN 1252112011); AXF LIMB STENT GRAFT (LN 1252601005); AXF LIMB STENT GRAFT (LN 1261902022)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR