MAUDE Adverse Event Report: ENDOLOGIX, INC AFX; SUPRARENAL AORTIC EXTENSION

Model Number A34-34/C100-O20

Device Problems Failure To Adhere Or Bond (1031); Collapse (1099); Detachment Of Device Component (1104); Fracture (1260); Leak/Splash (1354); Stretched (1601); Torn Material (3024)

Patient Problems Aneurysm (1708); Death (1802); Failure of Implant (1924); Pain (1994); Stenosis (2263)

Event Date 05/05/2017

Event Type  Death  

Manufacturer Narrative

The devices involved in the event will not be returned for evaluation and remain implanted in the patient.Devices remain implanted in the patient.

Event Description

The patient was initially implanted with a bifurcated stent graft and a suprarenal aortic extension.The patient presented emergently, approximately three (3) years post-op with complaint of abdominal pain.A ct was completed identifying a type iiia endoleak present.The physician elected for a secondary procedure implanting two infrarenal aortic extensions to seal the endoleak.At the conclusion of the secondary repair, the patient was reported as hemodynamically stable.

Manufacturer Narrative

At the completion of the complaint investigation, based on the information received, the clinical evaluation was able to confirm the following events; a type 1a endoleak, a type 3b endoleak from a partial suprarenal crown separation, a fracture of the suprarenal stent, a collapse of the suprarenal stent, a dilation of the main body stent as well as the sub-optimal positioning of the initial implanted stents.Additionally there was evidence to support the following observations; the placement of a left renal artery stent two days post initial implant and the migration of that implant; possible unintentional user error due to suboptimal positioning of the initial implanted devices.The most likely cause of the loss of seal, implant separation, compromised stent graft integrity, material separation (partial crown separation), stent cage fracture and stretched fabric (dilation of stent cage) of the aortic cuff was the use of strata material.However these conditions most likely exacerbated the failure: extra endovascular manipulation of the system; and/or lateral remodeling of the aorta, and progressive loss of overlap; and/or left renal stent migration to the right, lateral exterior aspect of the cuff.Note: a cautionary product use condition was detected; a left renal non endologix stent was placed two days post implant (and 35 months before this event) presumably due to a suboptimal position of the cuff which encroached the left renal artery; this event was reflective of either an unintentional user error or a procedure related issue.Due to lack of medical information, no off-label product use conditions could be identified.Notably, there was evidence to support the left renal stent migration occurred long before this event; the left kidney was markedly smaller that the right.This finding supported either medical non compliance or non recognition/treatment of the loss of fabric integrity of the cuff.It was likely that additional unintended user error was detected at the point of repair; the persistent leak might have been interpreted as an type ia endoleak (and thusly, the possibility of self-sealing was present, rather than a loss of fabric integrity).Due to medical equipment constraints, a third non endologix cuff was not able to be placed.Associated clinical harms for this failure included: cuff component - renal artery stenosis; type iiib endoleak; type ia endoleak; unable to exclude aneurysm; pain; aneurysm sac growth; and two secondary endovascular procedures.Additionally, the most likely cause of the type 3b endoleak and stent dilation was related to the anatomy, in combination with the progressive loss of overlap/aortic remodeling.There was protruding calcifications near the fabric breach, and there was evidence of stent cage dilation at the superior stent margin of the bifurcated graft which was accompanied by a significant stent cage stenosis near the bifurcation.No procedure or user related issues or off-label product use conditions were detected.Associated clinical harms included: type 3a endoleak with complete component separation; type iiib endoleak of the bifurcated stent; and, an additional endovascular repair (completed at the same event as the cuff).To date the event devices have not been returned, additional evaluation of the devices was not completed.The review of the manufacturing lot confirmed all devices met specifications prior to release.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 july 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 3b endoleak events reported for afx devices has been reduced to <0.2%.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 06/17/2015, field training was completed by 08/03/2015.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.No additional investigations of this reported complaint are planned, endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

Event Description

It was reported the patient had an additional repair procedure after the placement of the two infrarenal aortic extensions.The patient had a remaining type 1a endoleak and the physician was unable to place a non-endologix stent to repair the leak.The patient expired on (b)(6) 2017.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX, INC; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX, INC; 2 musick; irvine CA 92618
• Manufacturer Contact: michelle caulfield ; 2 musick; irvine, CA 92618 ; 6495984606
• MDR Report Key: 6609926
• MDR Text Key: 76589058
• Report Number: 2031527-2017-00283
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009011473
• UDI-Public: (01)00818009011473(17)191122
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

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
• Device Operator: Physician
• Device Expiration Date: 08/31/2016
• Device Model Number: A34-34/C100-O20
• Device Lot Number: 1056060-018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2017
• Initial Date FDA Received: 06/02/2017
• Supplement Dates Manufacturer Received: 07/28/2017
• Supplement Dates FDA Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 155