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

Model Number	BA28-100/I20-40
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/28/2018
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 a right internal aneurysm that grew to 5cm on (b)(6) 2018 as reported by physician (b)(6) at (b)(6) medical center.The reported aneurysm sac growth was discovered by angiogram on (b)(6) 2018.The patient was originally implanted with an afx bifurcated stent graft on (b)(6) 2015 by the reporting physician.During re-intervention, the patient was treated by implanting an afx iliac limb and extender on (b)(6) 2018 by physician (b)(6).The patient was asymptomatic prior to re-intervention.Post-secondary procedure the patient is in stable condition and is planned to be released on (b)(6) 2018.No endoleak was noted prior and post secondary procedure.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was unsubstantial evidence to support the following reported event: the sac growth complaint is unconfirmed due to a lack of comparison imaging.The right internal iliac aneurysm (32.5mm distal to the inferior stent margin of the stent) complaint is confirmed.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 to be stable condition post secondary endovascular procedure.The manufacturing lot review confirmed the involved device 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: 7566000
• Report Number: 2031527-2018-00513
• Device Sequence Number: 1523669
• Product Code: MIH
• UDI-Device Identifier: 00818009014207
• UDI-Public: (01)00818009014207(17)171103
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/28/2018

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: 11/03/2017
• Device Model Number: BA28-100/I20-40
• Device Lot Number: 1284147-024
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/28/2018
• Supplement Date Received by Manufacturer: 05/28/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 08/21/2018
• 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: 78 YR