MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number	A34-34/C100V
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354); Unintended Movement (3026)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	09/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Reference mdr# 2031527-2018-00698 for an event that occurred with the same patient for a type i a endoleak and extension implant.
Event or Problem Description
The patient was initially implanted with an afx device in 2014.During the investigation of (b)(4) it was discovered that approximately 2 years post implant, the patient underwent a procedure to place a vela suprarenal cuff for a possible migration and type 1a endoleak.As of the date of this report there have been no additional patient sequelae reported.The patient status is unknown and no additional information was provided.No additional information is available for this case in 2016.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was evidence to reasonably support the following observations: the reported type ia endoleak was not confirmed, however, there was significant sac growth (between 2014 and 2016, and not included in the event as reported) noted with low position of the infrarenal cuff (about 7mm below right renal artery); the additional finding of aneurysm sac growth was discovered during the review of the 26 month post implant ct scan.Event relatedness could not be determined.Procedure related harms for this complaint could not be determined.The final patient status was reported to be doing well post an intervention.The manufacturing lot review confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.
Event or Problem Description
Additional information received per clinical assessment confirming that aneurysm enlargement occurred between the initial implant and re-intervention in 2016.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8001355
• Report Number: 2031527-2018-00794
• Device Sequence Number: 1105058
• Product Code: MIH
• UDI-Device Identifier: 00818009013552
• UDI-Public: (01)00818009013552(17)150305
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2015
• Device Model Number: A34-34/C100V
• Device Lot Number: 1178434023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 01/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX-BIFURCATED STENT GRAFT-LOT: 1203530-019; AFX-BIFURCATED STENT GRAFT-LOT: 1203530-019
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR