MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number A28-28/C95-O20V

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following event of stent movement (5mm) of cuff (suprarenal stent graft extension).The cause of this stent movement of the cuff could not be determined.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

At the completion of the clinical assessment on (b)(6) 2019, for a pervious report event (2031527-2018-00963), clinical was able to find substantial evidence to support the following additional findings of stent movement (5mm) with no leak of the suprarenal stent graft extension (cuff).This report is for the stent movement of the cuff (suprarenal stent graft extension) only.All other details for this event can be found under the pervious report event (2031527-2018-00963).

• Brand Name: AFX
• Type of Device: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 8313447
• MDR Text Key: 135407708
• Report Number: 2031527-2019-00074
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009013637
• UDI-Public: (01)00818009013637(17)150122
• 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,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/07/2019

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: 01/22/2015
• Device Model Number: A28-28/C95-O20V
• Device Lot Number: 1203546-016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0006-2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR