MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA22-70/I16-30
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Occlusion (1984); Thrombosis (2100); Stenosis (2263)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation and remains 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 initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately three (3) years post initial procedure, the patient presented with a left side limb thrombosis at routine follow-up.However, the exact date of event is unknown.The physician plans to re-intervene and will continue to monitor the patient.There have been no additional patient sequelae reported.
Event or Problem Description
Additional information received confirming that a left-side limb thrombectomy was performed with bare metal stents in the left common and external iliacs, and the distal right-side common iliac was angioplastied on (b)(6) 2019.The vessels are patent and the patient is reportedly doing well.Clinical assessment confirmed that the initial case was off-label use due to the patient's aorto-iliac occlusive disease (aiod).In addition, clinical identified that distal aortic stenosis and a complete right common iliac artery (rcia) occlusion were present at one-day post initial implant procedure, and that a left common iliac artery (lcia) occlusion was present at discharge after secondary intervention was performed.
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 of a left common iliac artery (lcia) thrombosis with total occlusion from medical records only; medical imaging was requested but no response was received.The event is most likely user-related due to the patient's pre-existing severe aorto-iliac occlusive disease (off-label condition).No procedure-related harms were identified.The final patient status was discharged on postoperative day one post successful secondary endovascular procedure.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.Device iteration is "afx with duraply.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8537917
• Report Number: 2031527-2019-00198
• Device Sequence Number: 361596
• Product Code: MIH
• UDI-Device Identifier: 00818009010094
• UDI-Public: (01)00818009010094(17)170708
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

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: Health Professional
• Device Expiration Date: 07/08/2017
• Device Model Number: BA22-70/I16-30
• Device Lot Number: 1262199-003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 07/02/2019
• 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: Other; Required Intervention
• Patient Age: 57 YR