MAUDE Adverse Event Report: ENDOLOGIX AFX; SUPRARENAL AORTIC EXTENSION

Model Number A34-34/C100-O20

Device Problems Material Puncture/Hole (1504); Product Quality Problem (1506); Stretched (1601); Material Integrity Problem (2978)

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

Event Date 01/29/2019

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

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately 6.5 years post initial procedure, a type iiib endoleak of the proximal extension with neck (aneurysm) enlargement were detected during routine follow-up ct.The physician plans to re-intervene and the patient is reportedly in stable condition.There have been no additional patient sequelae reported.

Event Description

Additional information received per clinical assessment confirming that stent cage dilation of the proximal extension device was also present at the time of the reported event.Currently unable to confirm if re-intervention has been completed or scheduled for the patient.The complaint file will be reopened if additional information is received at a later time.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was unsubstantial evidence to support the following reported events: type iiib endoleak and sac growth complaint unconfirmed.There was substantial evidence to support the presence of stent cage dilation (32%) of the proximal extension device.The procedure related harms and device, user, procedure, or anatomy relatedness of this complaint could not be determined; unable to determine the contributing factors for the stent cage dilation due to a lack of comparative imaging.The final patient status was not reported.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 iiib endoleak.Endologix implemented the following corrective actions with the intent of reducing type iiib 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 july 2014.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8373702
• MDR Text Key: 137254236
• Report Number: 2031527-2019-00104
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

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: 03/31/2015
• Device Model Number: A34-34/C100-O20
• Device Lot Number: 1041753-012
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 01/30/2019
• Supplement Dates FDA Received: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0008-2019
• Patient Sequence Number: 1
• Treatment: AFX-BIFURCATED STENT GRAFT: 1042480-003; AFX-BIFURCATED STENT GRAFT: 1042480-003
• Patient Outcome(s): Other
• Patient Age: 75 YR