MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-70/I20-30
Medical Device Problem Codes	Partial Blockage (1065); Leak/Splash (1354); Material Puncture/Hole (1504); Material Integrity Problem (2978); Separation Problem (4043)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted devices involved in this event have not be returned for evaluation.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft, and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, a type 3b endoleak was reported.A secondary procedure was completed.The physician elected to do an open repair and explant the previously implanted devices.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was unable to find substantial evidence to support the following reported event of a type 3b and 3a endoleak with sac growth and explant of the device due to the lack of available medical records for review.However clinical was able to find substantial evidence to support the following additional findings of an occlusion of the right external iliac artery where a stent graft extension was placed.Due to lack of available medical records for review, clinical was unable to identify the type of stent graft extension that was occluded.The type 3b endoleak was mostly likely device related due to the use of strata material.The cause of the type 3a endoleak and occlusion of the right external iliac artery is unknown due to the lack of available medical records for review.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type iiib endoleak.Endologix implemented the following corrective actions with the intent of reducing type iiib endoleak events; 1.Upgraded graft material (i.E.Duraply) and 2.Updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place july 2014.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Conclusion code: remove code 11.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8118166
• Report Number: 2031527-2018-00909
• Device Sequence Number: 16557429
• Product Code: MIH
• UDI-Device Identifier: 00818009012623
• UDI-Public: (01)00818009012623(17)171110
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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: 11/10/2017
• Device Model Number: BA28-70/I20-30
• Device Lot Number: 1287855-004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 02/21/2019
• 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-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX-VELA SUPRARENAL:1280872-021; OVATION ILIAC LIMB, LOT # FS110916-03
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR