MAUDE Adverse Event Report: ENDOLOGIX AFX; INFRARENAL AORTIC EXTENSION

Model Number A34-34/C80

Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354); Stretched (1601); Unintended Movement (3026)

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

Event Date 10/22/2018

Event Type  Injury  

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following reported event: stent migration, type ia endoleak and stent cage dilation.The migration and proximal loss of seal (1a endoleak) were most likely user-related due to the off-label neck anatomy.The stent cage dilation was most likely device related due to use of strata material.Procedure related harms and the final patient status was not reported.The manufacturing lot evaluation confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.

Event Description

During the clinical assessment of a previously reported event (2031527-2018-00860), clinical was able to find substantial evidence to support the following additional findings of a type ia endoleak and stent cage dilation of the cuff (infrarenal aortic extension).This report is only for the cuff.Please refer to the previously reported event, if needed for additional information.

• Brand Name: AFX
• Type of Device: INFRARENAL 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: 8254390
• MDR Text Key: 133267803
• Report Number: 2031527-2019-00032
• 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
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2012
• Device Model Number: A34-34/C80
• Device Lot Number: W11-5067-003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2011
• 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
• Treatment: AFX-BIFURCATED STENT GRAFT:W11-3895-005
• Patient Outcome(s): Other
• Patient Age: 74 YR