MAUDE Adverse Event Report: ENDOLOGIX AFX2; LIMB STENT GRAFT

Model Number	I20-20/C55F SA
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	06/15/2017
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.
Event or Problem Description
An afx2 bifurcated stent graft, suprarenal cuff, and one limb extension was implanted to treat an abdominal aortic aneurysm.On (b)(6) 2017, approximately 1 year post-op, the patient returned for a follow-up ct which identified a type 1b endoleak from the right common iliac.The patient is scheduled to return at an unknown date for an investigative angiogram and possible re-intervention.There have been no additional patient sequelae reported and the patient will continue to be monitored.
Additional Manufacturer Narrative
At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following reported events; type 3b endoleak (bifurcated stent), diagnostic angiogram and future re-line post colon cancer treatment.Clinical also was able to find substantial evidence to support these additional findings; intraoperative type 1b endoleak, unplanned left hypogastric coiling, placement of an leia stent (non endologix), mechanical stenosis lcia, severe angulation, sac growth (6mm/12mon), anemia that required blood transfusions and medical management this assessment was based on the reported event and cumulative knowledge informed by past assessments of similar complaints.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The devices remain implanted in the patient and were not returned, no evaluation completed.The most likely cause of this event was procedure related; excessive ballooning and technical difficulties crossing the iliac area to perform an unplanned left hypogastric artery coiling and left iliac artery extension into the left external iliac artery at the initial implant procedure, to treat an intraoperative type ib endoleak.The severe off-label (near 180° hairpin turn) and moderate-severe calcification (cautionary) product use conditions of the left common iliac artery likely contributed to both of these device failures.There was evidence of intentional user error because anatomy was grossly outside of specifications; this was the main cause of the distal loss of seal at the implant procedure.Currently, the patient was discharged home, status post-surgical intervention to treat colon cancer.There was no evidence to suggest the planned stent relining was completed.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.

• Brand Name: AFX2
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6716319
• Report Number: 2031527-2017-00369
• Device Sequence Number: 13764917
• Product Code: MIH
• UDI-Device Identifier: 00818009011435
• UDI-Public: (01)00818009011435(17)190512
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/15/2017

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: 05/12/2019
• Device Model Number: I20-20/C55F SA
• Device Lot Number: 1484384011
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 09/11/2017
• 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
• Patient Age: 78 YR