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

Model Number	I20-13/C70F SA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
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)(4) 2018, endologix was made aware of a secondary procedure performed on (b)(6) 2018 to treat a lesion from patient stenosis that was noted on the distal right iliac limb.Patient was reported doing well post operative surgery.
Additional Manufacturer Narrative
Due to the lack of medical records and imaging scans, clinical was not able to confirm the reported stenosis of the right iliac limb or the secondary endovascular procedure.In addition, the lack of medical information could not help determine the cause of the inadequate stent graft integrity, procedure related harms or the final patient disposition 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: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7429529
• Report Number: 2031527-2018-00328
• Device Sequence Number: 19326881
• Product Code: MIH
• UDI-Device Identifier: 00818009011442
• UDI-Public: (01)00818009011442(17)181124
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 11/24/2018
• Device Model Number: I20-13/C70F SA
• Device Catalogue Number: F00805
• Device Lot Number: 1389180020
• 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: 05/08/2018
• 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: BIFURCATED STENT GRAFT, LOT 1260700018; LIMB STENT GRAFT, LOT 1252622018
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR