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

Model Number	BA28-100/I20-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Codes	Failure of Implant (1924); Rupture (2208)
Date of Event	02/25/2018
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 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 events of type 3a endoleak, aortic rupture or a successful endovascular procedure due to the lack of medical information.Medical records and images were requested and denied.The most likely cause of the loss of seal and the subsequent aortic rupture could not be determined due to a lack of any medical records or imaging.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type iiia endoleak.The root causes have been identified as; patient anatomy including large aneurysms, aneurysm sac angulation, significant aortic neck angulation and lack of thrombus; patient conditions including disease progression or anatomical changes post implant; off label product use including patient anatomy, overlap length, oversizing between components, and placement of the devices within the anatomy of the patient.Endologix implemented the following corrective actions to reduce the type iiia endoleak events; sizing guidance and instructions were updated in the ifu and released on 06/17/2015, field training was completed by 08/03/2015.Since the corrective actions were implemented the type iiia events have been reduced significantly and are well within the acceptable range per our risk assessment.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) 2015, the patient was implanted with a bifurcated stent and a suprarenal extension.On (b)(6) 2018, endologix was made aware of a type 3a endoleak, a leak between the suprarenal extension and the bifurcated stent.It was reported that the patient was admitted into the emergency room on (b)(6) 2018 for a ruptured aneurysm.The patient was relined with a non- endologix stent and the repair went well.There have been no additional patient sequelae reported.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7370467
• Report Number: 2031527-2018-00200
• Device Sequence Number: 48598
• Product Code: MIH
• UDI-Device Identifier: 00818009014207
• UDI-Public: (01)00818009014207(17)180219
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 02/27/2018

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: 02/19/2018
• Device Model Number: BA28-100/I20-40
• Device Lot Number: 1318756-027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/26/2018
• 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, LOT # 1252464-023
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR