MAUDE Adverse Event Report: ENDOLOGIX AFX; SUPRARENAL AORTIC EXTENSION

Model Number A34-34/C80-O20

Device Problems Leak/Splash (1354); Material Separation (1562); Torn Material (3024)

Patient Problem Failure of Implant (1924)

Event Date 07/28/2017

Event Type  Injury  

Event Description

The patient was initially implanted with a bifurcated stent and a suprarenal aortic extension on (b)(6) 2012.A routine follow up sonogram showed blood flow outside of the stent and a computed tomography (ct) showed a type 3b endoleak due to an increase in the main body stent cage diameter.On 2017 the patient had a secondary intervention where a diagnostic angiogram showed the patient had a crown separation of the suprarenal aortic extension.The physician implanted an additional bifurcated stent and a suprarenal aortic extension to seal the endoleak.At the completion of the secondary procedure the patient is reported as well.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

Based on the information received, clinical evaluation confirmed the reported endoleak iiib of the main body, endoleak iiib of the suprarenal cuff; complete separation of suprarenal crown and cuff; and secondary procedure.Clinical evaluation refuted the reported dilation of the main body stent, rather there was stent cage dilation of the cuff (32%).Clinical evaluation unable to confirm the favorable patient condition of stable.Additionally, clinical evaluation found that at 36 months post implant there was claudication, left iliac stent stenosis/kink and secondary endovascular procedure (non elgx stent).At 62 months post implant: endoleak ia due to crown 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 compromise stent graft integrity of suprarenal cuff (fabric breach and stretch) and loss of seal with complete crown separation was the use of strata material in combination with tortuous neck and aortic anatomy(anatomy-related).The most likely cause of the proximal loss of seal was a result of the progressive fabric breach.No procedure- or user-related contributing issues, and/or off-label and/or cautionary product use conditions were determined.Procedure-related harms could not be detected due to lack of medical information surrounding the implant procedure.Associated clinical harms for this device failure included: type iiib endoleak of the cuff; type ia endoleak; sac growth; and a secondary endovascular procedure.It was reported that the patient was discharged home in good condition.There have been no reports of further negative patient sequalae.The lot usage history shows one complaint pr6219 involving lot#: w11-6368 with a type iiia endoleak.There were no other units from the affected lots that have been involved in any similar complaints at this time.The device remains implanted in the patient and will not be returned for device evaluation.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.The above mentioned secondary endovascular procedure (non elgx stent) was previously reported under mfr# 2031527-2018-00078.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: michelle caulfield ; 2 musick; irvine, CA 92618 ; 9495984606
• MDR Report Key: 6822564
• MDR Text Key: 83724432
• Report Number: 2031527-2017-00430
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/28/2017

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: Health Professional
• Device Expiration Date: 01/31/2013
• Device Model Number: A34-34/C80-O20
• Device Lot Number: 1030002-014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/25/2017
• Supplement Dates Manufacturer Received: 01/26/2018
• Supplement Dates FDA Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2012
• 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): Required Intervention
• Patient Age: 69 YR