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

Model Number	BA28-120/I20-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/09/2017
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 , vela suprarenal, and limb stent graft on (b)(6) 2015.During follow-up on (b)(6) 2017 and per angiography, it was confirmed that the patient developed an iliac aneurysm distal to the previously implanted limb stent graft.The patient was asymptomatic during this follow-up.The secondary case for this patient was completed on the same date (b)(6) 2017 and the patient was implanted with a new afx limb stent graft.No devices were explanted during this secondary procedure.
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: the developed iliac aneurysm distal to graft (at the left common iliac artery).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 not reported.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.Additional information: add method code 3331, 4112.Add result code 213.Add conclusion code 22, 50, 4310.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7445887
• Report Number: 2031527-2018-00283
• Device Sequence Number: 11204765
• Product Code: MIH
• UDI-Device Identifier: 00818009011992
• UDI-Public: (01)00818009011992(17)180422
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/09/2017

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: 04/22/2018
• Device Model Number: BA28-120/I20-40
• Device Lot Number: 1331260-005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: 03/09/2017
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 09/18/2018
• 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-LIMB STENT GRAFT - LOT 1342610-005; AFX-VELA SUPRARENAL - LOT 1341528-003; AFX-LIMB STENT GRAFT - LOT 1342610-005; AFX-VELA SUPRARENAL - LOT 1341528-003
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR