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

Model Number	BA28-120/I20-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/07/2016
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
The patient was implanted with an afx bifurcated stent graft and vela suprarenal on (b)(6) 2015.During follow-up, bilateral type 1b endoleaks were observed and the patient was asymptomatic.The secondary case for this patient was completed on (b)(6) 2016 and the patient was implanted with an afx extender and limb stent graft.No devices were explanted and the patient tolerated the procedure well and was discharged the following day.
Event or Problem Description
Clarification: endologix became aware of bilateral 1b endoleaks approximately three days prior [(b)(6) 2016 ] to the secondary procedure as reported by physician (b)(6) at (b)(6) medical center.The reported endoleaks were discovered during follow-up on an unknown date, and the patient was asymptomatic.As the exact date of event is unknown, the best estimate (b)(6) 2016 was used which is the date of re-intervention.The patient was originally implanted with an afx bifurcated stent graft and one (1) afx vela suprarenal on (b)(6) 2015 by physician (b)(6).During re-intervention, the patient was treated by implanting an afx limb stent graft and one (1) ovation ix extender on (b)(6) 2016 by the reporting physician.The patient tolerated the procedure well and was discharged the following day.No devices were explanted at that time.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following reported event: type ib endoleak of the distal left iliac.Device, user, procedure or anatomy relatedness of this complaint could not be determined based on the information shared with endologix to review.Procedure-related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was reported as doing well, and discharged the day following the procedure.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.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7445709
• Report Number: 2031527-2018-00304
• Device Sequence Number: 19113732
• Product Code: MIH
• UDI-Device Identifier: 00818009011992
• UDI-Public: (01)00818009011992(17)171022
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

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: Physician
• Device Expiration Date: 10/22/2017
• Device Model Number: BA28-120/I20-40
• Device Lot Number: 1283293-006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: 12/12/2016
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 06/18/2018
• 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 1282830-020
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR