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

Model Number	BA28-90/I16-30
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Unspecified Infection (1930); Inflammation (1932); Pain (1994)
Date of Event	04/25/2018
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
The patient was originally implanted with an afx bifurcated stent graft and vela suprarenal on (b)(6) 2016.Endologix became aware of a complaint against our device on (b)(6) 2018 when the patient presented at (b)(6) with a contained rupture.After transfer to (b)(6), it was determined there was no rupture but a type 2 endoleak and a potential mycotic aneurysm.Aspiration was done and the fluid sent in for culture, but the results are still pending.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Additional information received confirming that the type ii endoleak and mycotic aneurysm were diagnosed by ct, then it was aspirated.The patient is experiencing pain from the inflammation and it is unknown if any medication was administered.
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 events: infection (mycotic aneurysm) and type ii endoleak from the inferior mesenteric artery.Device, user, procedure or anatomy relatedness of this complaint could not be determined based on the information shared with endologix to review.There were no procedure related harms for this complaint.The final patient status was discharged home with hospice on the fifth post operative day.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.(b)(4).

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7503605
• Report Number: 2031527-2018-00432
• Device Sequence Number: 13483643
• Product Code: MIH
• UDI-Device Identifier: 00818009010247
• UDI-Public: (01)00818009010247(17)181211
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 04/25/2018

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: 12/11/2018
• Device Model Number: BA28-90/I16-30
• Device Lot Number: 1265993-011
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 04/25/2018; 04/25/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 07/24/2018; 10/09/2018
• 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 1252082-018; AFX-VELA SUPRARENAL - LOT 1252082-018
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR