MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number	BA25-120/I20-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Hole In Material (1293); Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	12/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Devices remain implanted in the patient.
Event or Problem Description
It was reported the patient had an initial implant on (b)(6) 2016 with a bifurcated stent, an infrarenal aortic extension, and a suprarenal aortic extension.A follow up computed tomography angiogram (cta) showed aneurysm sac growth with a potential type 2 or type 1 endoleak.The patient is in stable condition and the physician is planning to complete a secondary intervention.The patient has not been scheduled for a secondary endovascular procedure at this time.There have been no additional adverse events reported for this patient.
Additional Manufacturer Narrative
At the completion of the investigation, based on the information received the following were confirmed; endoleak type ia and endoleak type ii.Due to lack of medical records and imaging surround the events, secondary endovascular repair could not be verified.Additionally there was evidence to reasonably support the following observations; endoleak type iiib.The manufacturing lot evaluation confirmed all devices met specifications prior to release.Device was not returned, no evaluation completed.Clinical was unable to find evidence to reasonably suggest contributing factor to the reported event due to limited available patient information.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type 3b endoleak.Endologix implemented the following corrective actions with the intent of reducing type 3b 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 3b 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 3b endoleak events reported for afx devices has been reduced to <0.2%.
Event or Problem Description
Additional information was obtained since the initial reporting.On (b)(6) 2017, a secondary procedure was conducted to reline with an ovation device.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6248186
• Report Number: 2031527-2017-00017
• Device Sequence Number: 1543433
• Product Code: MIH
• UDI-Device Identifier: 00818009011985
• UDI-Public: (01)00818009011985(17)171212
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2016

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: 12/12/2017
• Device Model Number: BA25-120/I20-40
• Device Lot Number: 1283306-043
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/13/2016
• Supplement Date Received by Manufacturer: 12/13/2016
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 07/17/2017
• 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: AORTO UNI-ILIAC [INFRARENAL]- (B)(4); AORTO UNI-ILIAC [SUPRARENAL]- (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR