MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-90/I16-30
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device quality records showed that the device demonstrated compliance to established procedures and specifications at the time of manufacture.
Event or Problem Description
An afx bifurcated and suprarenal was initially implanted.The three (3) year routine follow-up showed the presence of a type iiia endoleak.A re-intervention was completed at a different hospital where an additional suprarenal stent graft was implanted to bridge the components successfully resolving the endoleak.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
The root cause for the reported type iiia endoleak with component separation is most likely anatomy related due to aortic remodeling; the pre implant neck angulation of 48°, increasing to 64° with aortic remodeling, likely contributed to this event.Procedure related harms for this complaint could not be determined.The final patient status was reported to be without additional sequelae post successful secondary repair.In addition, the clinical assessment determined that there was evidence to reasonable suggest sac growth of 16mm occurred that was not included in the event as reported.The sac growth was discovered on october 12, 2018 during review of the 38 month post implant ct scan.The lot history records related to the subject device referenced in this complaint record were reviewed for potential contributing factors for the failure mode(s) described in this event.A review of the device quality records showed that the device(s) demonstrated compliance to established procedures and specifications at the time of manufacture.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7904201
• Report Number: 2031527-2018-00742
• Device Sequence Number: 168438
• Product Code: MIH
• UDI-Device Identifier: 00818009010230
• UDI-Public: (01)00818009010230(17)170619
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2017
• Device Model Number: BA25-90/I16-30
• Device Catalogue Number: BA25-90/I16-30
• Device Lot Number: 1252256-006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 01/04/2019
• 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: SUPRARENAL - 1252409-020
• Outcome Attributed to Adverse Event: Required Intervention