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

Model Number	BEA28-110/I16-30
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	07/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the clinical assessment for this event, the most likely cause of the difficulty to advance the afx2 delivery system and the reported kinked afx sheath was determined to be anatomy related, due to the significant common iliac artery calcification and angulation.The cautionary product use condition of access morphology with significant calcification and tortuosity likely contributed to the event.No procedure-related, and user-related issues were determined.Off label product use conditions could not be determined due to the lack of pre-operative imaging.The most likely cause of the difficulty to withdraw the yellow contralateral wire could not be determined.However, the cautionary product use condition of significant iliac artery tortuosity as well as the difficulty between the contralateral wire cover and the non-endologix introducer sheath likely contributed tot he procedural harm of dissection of the distal left common iliac artery.The final patient disposition was discharged on post-operative day one.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.
Event or Problem Description
An afx2 bifurcated stent graft system was implanted to treat an abdominal aortic aneurysm.During the implant procedure, it was observed that the yellow sleeve of the 035 wire was having extreme difficulty in passing through the 7f sheath.It was also difficult to load the afx2 device into the sheath.Eventually the sheath buckled and both the sheath and device were pulled out and exchanged for new devices.Upon clinical review of the reported event, it was discovered that the patient had a left common iliac dissection during the procedure.As of the date of this report, there have been no additional patient sequelae reported.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6993678
• Report Number: 2031527-2017-00567
• Device Sequence Number: 1184397
• Product Code: MIH
• UDI-Device Identifier: 00818009014580
• UDI-Public: (01)00818009014580(17)180705
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 10/24/2017

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: 07/05/2018
• Device Model Number: BEA28-110/I16-30
• Device Lot Number: 1719186013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/01/2017
• 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
• Patient Age: 86 YR