MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB EXTENSION

Model Number I20-13/C88F

Device Problems Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Leak/Splash (1354); Material Puncture/Hole (1504); Stretched (1601)

Patient Problems Aneurysm (1708); Failure of Implant (1924)

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.

Event Description

Endologix became aware of a type 3a endoleak at the left common iliac artery and separation of the limb extension and main body, causing the abdominal aortic aneurysm to grow (to an unknown diameter) on (b)(6) 2018 as reported by physician karl dittrich at presbyterian hospital.Approximately seven years post-op the patient presented for a routine follow-up.As the exact date of event is unknown, the best estimate (b)(6) 2018 was used.The patient was originally implanted with an afx bifurcated stent graft, one (1) afx infrarenal aortic extension, and one (1) afx limb extension on (b)(6) 2011 by physician (b)(6) at university of (b)(6) hospital.During re-intervention, the patient was treated by implanting one (1) afx limb stent graft on (b)(6) 2018 by the reporting physician.The patient is in good status.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following observations: the type iiia endoleak of the lcia is refuted, rather the complaint is a type iiib of the limb stent.The clinical assessment also determined that there was evidence to reasonably suggest stent cage dilation of the limb stent of 27% (stretched and breached) occurred that was not included in the event as reported.The stent cage dilation was discovered during review of the 81 month post implant ct scan.The complaint is most likely device related (use of strata material).Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was reported to be in good condition post secondary endovascular repair.The manufacturing lot review confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type 3a 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 3a endoleak events; sizing guidance and instructions were updated in the ifu and released on (b)(6) 2015, field training was completed by 03 aug 2015.Since the corrective actions were implemented the type 3a events have been reduced significantly and are well within the acceptable range per our risk assessment.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; upgraded graft material (i.E.Duraply) and updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place (b)(6) 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 iiib endoleak events reported for afx devices has been reduced to less than 0.2%.(b)(4).

• Brand Name: AFX
• Type of Device: LIMB EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7609405
• MDR Text Key: 111321210
• Report Number: 2031527-2018-00547
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

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
• Device Operator: Physician
• Device Expiration Date: 10/11/2011
• Device Model Number: I20-13/C88F
• Device Lot Number: W11-4756-009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 05/29/2018
• Supplement Dates FDA Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX-BIFURCATED STENT GRAFT:W11-4308-007; AFX-INFRARENAL AORTIC EXTENSION - LOT W11-4711-011; AFX-LIMB EXTENSION - LOT W11-4756-009; AFX-INFRARENAL AORTIC EXTENSION - LOT W11-4711-011; AFX-LIMB EXTENSION - LOT W11-4756-009
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR