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

Model Number	BEA22-60/I13-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	03/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2018, endologix was made aware of a patient who, a few months ago ((b)(6) 2017), was placed with an afx device to treat for aiod (aorto iliac occlusive disease).Rep reported that the physician at the time did not want to go all the way up the aorta due to a large chunk of calcium.Physician thought putting the grafton below would alleviate the patient's symptoms, but the patient symptoms were only half better.Physician is electing add another device up top to cover the calcium and open the aorta again.This is not a device failure but a physician preference in both the primary case landing low and the secondary case which will be done next week putting another piece higher (off label procedure).Rep noted that he went over the case with the physician yesterday at (b)(6) hospital in (b)(6).Patient is currently stable and the secondary procedure is scheduled for (b)(6) 2018.
Additional Manufacturer Narrative
A device failure could not be determined, as well as procedure related harms and the final patient disposition due to lack of medical records and/or imaging.Clinical was unable to confirm the reported aiod (aortoiliac occlusive disease) and scheduled re-intervention.There have been no further reports of negative patient sequelae.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and will not returned and no evaluation will be completed.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7429497
• Report Number: 2031527-2018-00329
• Device Sequence Number: 13966303
• Product Code: MIH
• UDI-Device Identifier: 00818009015068
• UDI-Public: (01)00818009015068(17)180927
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup
• Report Date (Section B): 03/23/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 09/27/2018
• Device Model Number: BEA22-60/I13-40
• Device Catalogue Number: F00820-68
• Device Lot Number: 1744148010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 05/16/2018
• 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: Other; Required Intervention
• Patient Age: 81 YR