MAUDE Adverse Event Report: ENDOLOGIX AFX; SUPRARENAL AORTIC EXTENSION

Model Number	A25-25/C75-O20
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/11/2016
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 initial implant was completed with a 1 bifurcated stent graft and 2 cuffs.There was no ballooning done at the end of the procedure and there was reportedly bad overlap between the grafts due to calcifications in the neck.This resulted in a type ia endoleak and a type iiia endoleak between the components.The physician is planning to re-intervene at a later a date.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
Based on the clinical assessment for this event, the most likely cause of the proximal loss of seal was found to be unknown/undetermined due to the lack of medical records and imaging surrounding the event.Procedure related harms and the final patient disposition could not be determined.There have been no reports of further (b)(6) patient sequelae.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.(b)(4).

• Brand Name: AFX
• Common Device Name: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6884381
• Report Number: 2031527-2017-00478
• Device Sequence Number: 745865
• Product Code: MIH
• UDI-Device Identifier: 00818009010353
• UDI-Public: (01)00818009010353(17)180916
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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: 09/16/2018
• Device Model Number: A25-25/C75-O20
• Device Lot Number: 1379478002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 01/22/2018
• 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