MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number	A25-25/C75V
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	06/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2016 a patient with an abdominal aortic aneurysm was treated with an afx system.Approximately one year post-op ((b)(6) 2016) a type 1a endoleak was observed.A re-intervention was done on an unknown date and the type 1a leak was resolved.As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.
Additional Manufacturer Narrative
At the completion of the clinical evaluation, based on the information received, there were confirmed evidence to support the following reported event.An endoleak type 1a with a secondary procedure (unknown type) was noted.A clinical assessment was required, but no medical information was received.This assessment was based upon the reported event, cumulative knowledge informed by past assessments of similar complaints, and/or other non-medical, relative information such as, but not limited to: still photographs; videos; sizing/case planning sheet/summary cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the loss of seal could not be determined due to lack of relevant medical information.Procedure-related, anatomy-related and user-related issues, off label, or cautionary product use conditions could therefore not be determined.Associated clinical harms for this event included: type ia endoleak and a secondary procedure.The final patient disposition was reported to have no additional negative patient sequelae and patient will be continued to be monitored.This complaint is not capa eligible at this time.The review of manufacturing lot confirmed all devices met specifications prior to release and history shows that no other units from the affected lots have been involved in any similar complaints at this time.The device still remains implanted in the patient and no device will not be returned for evaluation.These types of events will be monitored and trended as part of the quality system.Correction: all manufacturers.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6716517
• Report Number: 2031527-2017-00373
• Device Sequence Number: 1852915
• Product Code: MIH
• UDI-Device Identifier: 00818009013491
• UDI-Public: (01)00818009013491(17)180928
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 09/28/2018
• Device Model Number: A25-25/C75V
• Device Lot Number: 1252121009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/16/2017
• Supplement Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 07/16/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 96