MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; SUPRARENAL AORTIC EXTENSION

Model Number A25-25/C95-O20

Device Problem Stretched (1601)

Patient Problem Failure of Implant (1924)

Event Date 09/26/2017

Event Type  Injury  

Manufacturer Narrative

At the completion of the clinical evaluation, based on the information received, there were evidence to support the reported endoleak.It was confirmed that patient had an el3a (mfg report mdr: 2031527-2017-00542); a complete component separation; and a secondary endovascular intervention.In addition, a stent cage dilation of the cuff and main body stent (mfg report mdr: 2031527-2017-00542),( 24% and 36% respectively).The most likely cause of the loss of seal and implant separation was the use of strata material in combination[ due to the presence of stent cage dilation] with severe aortic remodeling (anatomy).The patient's disposition post repair could not be ascertained; there were no further reports of negative patient sequelae.The review of manufacturing lot confirmed all devices met specifications prior to release.The lot usage history shows that no other units from the affected lots have been involved in any similar complaints at this time.No device will be returned as the device remains implanted in the patient.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

Event Description

The patient was initially implanted with a bifurcated and suprarenal device in 2012.On (b)(6) 2017, the patient presented his recent ct to the physician.An endoleak type iiia with complete component separation was observed.The physician elected to reline with a vela cuff and ovation to successfully resolve the leak.No additional patient sequela has been reported.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7165604
• MDR Text Key: 96411059
• Report Number: 2031527-2018-00007
• 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: 09/27/2017

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: Physician
• Device Expiration Date: 08/31/2012
• Device Model Number: A25-25/C95-O20
• Device Catalogue Number: F00395
• Device Lot Number: W11-4468-044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2011
• 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: BIFURCATED STENT GRAFT LOT W11-5098-013
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR