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

Model Number	BEA25-70/I20-30
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.Device iteration is afx2.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent.Approximately 1.5 years post initial procedure, a type iiia endoleak with component separation was detected during routine follow-up.The physician elected to treat the patient by implanting an infrarenal afx device on (b)(6) 2019.The endoleak was confirmed resolved and the patient reportedly is doing well.As of date, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the reported event of a type iiia endoleak of the aortic components.The clinical assessment also determined that there was evidence to reasonably suggest a postoperative popliteal thrombus occurred with a resultant additional secondary endovascular procedure (thromboembolectomy) that was not included in the event as reported; these findings were discovered during a review of the 21-month discharge summary.The event is most likely anatomy-related due to aortic remodeling, which was evident by the increase in infrarenal angulation from 36 degrees at 1-month post initial evar to 63 degrees at 21-months post initial evar.The procedure-related harm identified was the thromboembolectomy, and the final patient status was discharged on the fourth postoperative day following the secondary procedure.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.Result code ¿ remove 3233.Conclusion code ¿ remove 11.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 8857038
• Report Number: 2031527-2019-00349
• Device Sequence Number: 14090326
• Product Code: MIH
• UDI-Device Identifier: 00818009014832
• UDI-Public: (01)00818009014832(17)180714
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2019

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: 07/14/2018
• Device Model Number: BEA25-70/I20-30
• Device Lot Number: 1720978-006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL: 1498103-016; AFX VELA SUPRARENAL: 1727655-003; AFX VELA SUPRARENAL: 1498103-016; AFX VELA SUPRARENAL: 1727655-003
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR