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

Model Number	BA22-90/I16-30
Medical Device Problem Codes	Hole In Material (1293); Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following reported events of type 3b endoleak of the main body.The most likely cause of the compromised stent graft integrity (type 3b endoleak) was related to the suture holes in the left iliac limb of the main body.The final patient disposition was discharged on postoperative day one.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.The type iiib endoleak rate for afx manufactured and implanted before these corrective actions were put in place is trending at 2.5%.Since the corrective actions were implemented, the type iiib endoleak events reported for afx devices has been reduced to <0.2%.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.These types of events will be monitored and trended as part of the quality system.
Event or Problem Description
On (b)(6) 2014, the patient was initially implanted with a bifurcated stent and a suprarenal extension.On (b)(6) 2017, endologix was made aware of a type 3a and 2 endoleaks with sac growth.On (b)(6) 2017, the physician discovered migration of the extension during the secondary procedure.The physician elected to place another extension to resolve this reported event.The patient will be monitored.There have been no additional patient sequelae reported.This event was previously reported under 2031527-2017-00607.During the clinical assessment of the above reported, a type 3b endoleak of the main body was discovered on (b)(6) 2018.The patient is being monitored.There have been no additional patient sequelae reported.This report is only for the bifurcated stent graft (main body) for the type 3b endoleak.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7215986
• Report Number: 2031527-2018-00050
• Device Sequence Number: 10797061
• Product Code: MIH
• UDI-Device Identifier: 00818009010223
• UDI-Public: (01)00818009010223(17)170724
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/18/2018

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: 07/24/2017
• Device Model Number: BA22-90/I16-30
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 01/24/2018
• 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 EXTENSION/ CUFF, LOT # 1203541-004
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR