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

Model Number	BA28-70/I16-30
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Rupture (2208)
Date of Event	10/08/2017
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
On (b)(6) 2014, the patient was initially implanted with a bifurcated stent and a suprarenal extension.On (b)(6) 2017, a type 3a endoleak was discovered.The physician elected to implant an additional suprarenal extension to seal the endoleak.There have been no additional patient sequelae reported.
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 type 3a endoleak and a secondary procedure.Clinical was able to find substantial evidence to support the following additional findings; at 11 months post implant there was sac growth due to a type 2 endoleak and a secondary endovascular procedure (coiling of the ima) was performed, at 12 months post implant there was a left common femoral artery pseudoaneurysm and covered stent placement and at 35 months post implant the was sac growth with a rupture and component separation.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the loss of seal and component separation was the undetected/untreated loss of overlap due to the non-contrast surveillance, a cautionary product use condition.The subsequent lateral movement that caused the loss of overlap was likely exacerbated by continual sac growth from a large inferior mesenteric artery, also a cautionary product use condition.The final disposition of the patient is not known due to the lack of medical information.Procedure-related harms included a left common femoral artery pseudoaneurysm that was treated with a covered stent status post diagnostic angiogram to evaluate the type ii endoleak at 12 months post implant.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 (b)(6) 2015, field training was completed by (b)(6) 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.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7004088
• Report Number: 2031527-2017-00579
• Device Sequence Number: 1197517
• Product Code: MIH
• UDI-Device Identifier: 00818009010117
• UDI-Public: (01)00818009010117(17)170805
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2017

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: 08/05/2017
• Device Model Number: BA28-70/I16-30
• Device Lot Number: 1268459-019
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 01/04/2018
• 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 # 1252456-023
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR