MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-80/I13-40
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Endologix will continue to investigate the reported event.The patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.
Event or Problem Description
An afx bifurcated stent graft system was implanted to treat an abdominal aortic aneurysm.The patient returned for a follow-up where physician observed a potential endoleak through angiographic review.A re-intervention is scheduled at a later date where physician will perform a full reline using an afx2 bifurcated device.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
At the completion of the clinical evaluation, based on the information received, there were confirmed evidence to support the following reported event.It was confirmed that a non-endologix stent had been placed on the implant to correct a flow issue.Patient also had an endoleak type 3b on the main body and persistent endoleak post re-lining.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the compromised stent graft integrity of the main body stent was intentional user-error caused by the suboptimal placement of non endologix iliac stents in the mid aorta and concomitant use of non endologix products at implant.The patient was reported as doing well post an endovascular repair, however, there was evidence to support the reported persistent leak (indeterminate) post repair.The review of manufacturing lot confirmed all devices met specifications prior to release.The lot usage history shows that no other units from the affected lots have been involved in any similar complaints at this time.The device still remains implanted in the patient.No device will be returned for evaluation.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.(b)(4).

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6994835
• Report Number: 2031527-2017-00571
• Device Sequence Number: 11085772
• Product Code: MIH
• UDI-Device Identifier: 00818009010179
• UDI-Public: (01)00818009010179(17)180105
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2017

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: 01/05/2018
• Device Model Number: BA25-80/I13-40
• Device Lot Number: 1267159026
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 01/04/2018
• 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: 81 YR