MAUDE Adverse Event Report: ENDOLOGIX AFX; AFX INTRODUCER SYSTEM

Model Number	S17-45
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/23/2018
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
During an initial procedure, an incident occurred during an aiod + aortic ulceration case.During delivery of the bifurcated stent, the sheath came back and wouldn't track any further.The physician advanced the device and sheath together.The physician experienced difficulty advancing and orienting the afx bifurcation.The afx bifurcation was positioned then deployed as expected.Upon removal of the device the physician felt the sheath concertina and elected to remove the stent and sheath together.Upon removing the device, damage of the sheath was observed with what appeared to be a portion of the intima removed as well.As of the date of this report, there have been no additional patient sequelae reported.No further information is available at this time.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was unsubstantial evidence to support the reported events of difficulty to advance, damaged component, and vessel damage.This event is most likely user-related due to off-label aorto-iliac structure.Procedure related harms and the final patient status were not reported.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.Remove data.Conclusion code - remove 11.

• Brand Name: AFX
• Common Device Name: AFX INTRODUCER SYSTEM
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8087568
• Report Number: 2031527-2018-00872
• Device Sequence Number: 16477004
• Product Code: MIH
• UDI-Device Identifier: 00818009011381
• UDI-Public: (01)00818009011381(17)210330
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: S17-45
• Device Lot Number: 1923633049
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 01/22/2019
• 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: AFX2-BIFURCATED STENT GRAFT-LOT-1782942006
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR