MAUDE Adverse Event Report: ENDOLOGIX AFX; SUPRARENAL AORTIC EXTENSION

Model Number A34-34/C80-O20

Device Problems Detachment Of Device Component (1104); Hole In Material (1293); Leak/Splash (1354); Migration or Expulsion of Device (1395); Stretched (1601); Material Integrity Problem (2978); Torn Material (3024); Unintended Movement (3026)

Patient Problems Aneurysm (1708); Failure of Implant (1924); Thrombus (2101); Stenosis (2263)

Event Date 06/20/2017

Event Type  Injury  

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 Description

An afx bifurcated stent graft was implanted with a vela suprarenal aortic extension to treat an abdominal aortic aneurysm.The patient underwent a secondary procedure to resolve a reported type iiia due to component disconnection at approximately one year post-op.The patient presented for a routine follow-up approximately 4 years post-implant where imaging indicated the presence of a type iiib endoleak and proximal device migration.The physician is planning to re-intervene.

Manufacturer Narrative

At the completion of the complaint investigation, based on the information received, the clinical assessment was able to confirm a type 3b endoleak of the suprarenal cuff, a type 1a endoleak and migration of the proximal extensions.Additionally the clinical assessment found the patient had aneurysm sac growth, dilation of the suprarenal aortic extension and stenosis in the overlap of the main body and the cuff overlap due to thrombus.The most likely cause of the type 3b endoleak was related to the strata graft material of the proximal extension.The compromised fabric allowed for dilation of the stent 62% above nominal.The most likely cause of the implant migration was related to the off label short neck length.Additionally, the dilated stent of the suprarenal cuff in conjunction with a 98 degree infrarenal angulation and subsequent lack of infrarenal cuff stent apposition likely contributed to the event.No procedure-related, user-related issues, or cautionary product use conditions were determined.The most likely cause of the stenosis in the main body and cuff overlap area was related to the 98 degree infrarenal angulation.The stenosis located at the apex of the angulation contained mural thrombus that created the decreased flow lumen.The event devices remain implanted in the patient and were not available for further evaluation.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; 1.Upgraded graft material (i.E.Duraply) and 2.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 3b endoleak events reported for afx devices has been reduced to less than 0.2%.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

Additional information received, the patient had a secondary procedure on (b)(6) 2017.The physician elected to reline the stents with ovation devices including an aortic main body and four iliac limbs.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6730639
• MDR Text Key: 80619141
• Report Number: 2031527-2017-00379
• 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: 06/20/2017

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: 10/31/2015
• Device Model Number: A34-34/C80-O20
• Device Lot Number: 1025855-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2017
• Initial Date FDA Received: 07/20/2017
• Supplement Dates Manufacturer Received: 09/20/2017
• Supplement Dates FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2012
• 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