MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED STENT GRAFT

Model Number	BA28-110/I16-30
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
Endologix became aware of an abdominal aortic aneurysm sac growth on (b)(6) 2018 as reported by physician (b)(6) at (b)(6).The reported sac growth was discovered per ct scan on an unknown date with no evidence of an endoleak.As the date of event is unknown, the best estimate (b)(6) 2018 was used.The patient was originally implanted with an afx bifurcated and vela suprarenal on (b)(6) 2015 by the reporting physician.During re-intervention, the patient was treated by implanting an afx2 bifurcated stent graft, vela suprarenal, and vela infrarenal on (b)(6) 2018 by physician (b)(6).The patient did well and went home the next day.
Additional Manufacturer Narrative
A clinical evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Requests were made on (b)(6) 2018, (b)(6) 2018 and (b)(6) 2018 and no response was received.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.The of 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.(b)(4).

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7565827
• Report Number: 2031527-2018-00519
• Device Sequence Number: 2354775
• Product Code: MIH
• UDI-Device Identifier: 00818009014160
• UDI-Public: (01)00818009014160(17)171013
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 10/13/2017
• Device Model Number: BA28-110/I16-30
• Device Lot Number: 1283280-005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 08/01/2018
• 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-VELA SUPRARENAL - LOT 1252484-016; AFX-VELA SUPRARENAL - LOT 1252484-016
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR