MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-110/I20-30
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	08/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.This patient had a previous reported event under 2031527-2018-00341.On (b)(6) 2017 a secondary procedure was performed due to an indeterminate endoleak from the left common iliac (lci) and a 1b endoleak from the right common iliac (rci).Two (2) ovation stent graft extensions were implanted in the lci and two (2) ovation stent graft extensions were implanted in the rci.The endoleak was resolved.
Event or Problem Description
On (b)(6) 2015, the patient was implanted with an bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm.Approximately two (2) years post-op, endologix was made aware of a type 2 endoleak and an indeterminate endoleak (possible 3b of the main body).A secondary procedure has been scheduled to reline the stent graft.There have been no additional patient sequelae reported, and the patient will continue to be monitored.
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 able to find substantial evidence to support the following events of a type 2 endoleak and a 3b endoleak of the main body.This type 3b endoleak is mostly likely device related due to the use of strata material.The type 2 endoleak is not a device related failure but is related to the patient's anatomy.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%.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.
Event or Problem Description
Updated information: a secondary procedure was completed on 09/20/2018.The physician elected to reline the original implant with the ovation sealing system.Also this patient had a previous reported event under 2031527-2018-00341.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7896461
• Report Number: 2031527-2018-00730
• Device Sequence Number: 2347273
• Product Code: MIH
• UDI-Device Identifier: 00818009014214
• UDI-Public: (01)00818009014214(17)180519
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/21/2018

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: 05/19/2018
• Device Model Number: BA28-110/I20-30
• Device Lot Number: 1342785-010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/14/2018
• 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: STENT GRAFT EXTENSION, LOT # FS090117-39; STENT GRAFT EXTENSION, LOT # FS081617-69; STENT GRAFT EXTENSION, LOT # FS092017-65; STENT GRAFT EXTENSION, LOT # FS093017-29; SUPRARENAL EXTENSION, LOT # 1252492026
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR