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

Model Number	BA28-70/I20-30
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Pain (1994); Rupture (2208); Blood Loss (2597)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2015, the patient was initially implanted with a bifurcated stent and a suprarenal extension.On (b)(6) 2017, the devices were explanted due to a rupture and type 3a endoleak with separation.The patient was reported as stable.
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 a type 3a endoleak with implant separation, rupture and a secondary endovascular procedure (explant).Additionally clinical was able to find the following additional findings of sac growth and 3 liters (estimated) blood loss.The most likely cause of the loss of seal could not be determined due to a lack of any relevant imaging studies.The patient was discharged on the sixteenth post-operative day in stable condition.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; 1.Patient anatomy including large aneurysms, aneurysm sac angulation, significant aortic neck angulation and lack of thrombus; 2.Patient conditions including disease progression or anatomical changes post implant; 3.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; 1.Sizing guidance and instructions were updated in the ifu and released on 06/17/2015, 2.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.Correction: (b)(4).

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7086959
• Report Number: 2031527-2017-00657
• Device Sequence Number: 11065246
• Product Code: MIH
• UDI-Device Identifier: 00818009012623
• UDI-Public: (01)00818009012623(17)171217
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/17/2017
• Device Model Number: BA28-70/I20-30
• Device Lot Number: 1251891-010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 04/06/2018
• 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 # 1350006-010; SUPRARENAL EXTENSION, LOT # 1350006-010
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR