MAUDE Adverse Event Report: ENDOLOGIX AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA22-40/I13-40
Medical Device Problem Codes	Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Deformation (2976)
Health Effect - Clinical Codes	Failure of Implant (1924); Ischemia (1942); Pain (1994); Thrombus (2101); Stenosis (2263)
Date of Event	07/21/2018
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 with the afx2 abdominal aortic aneurysm stent.Approximately three (3) months post initial procedure, the patient presented to the emergency room with pain in the left foot; the ct showed occlusion in the left limb of the device.The physician elected to treat the patient by implanting two (2) bare metal balloon expandable stents (non-endologix) and the procedure concluded without incident.The patient was doing well post 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: occlusion within the device with left leg ischemia.In addition, stent buckling with stenosis and thrombus of the right common iliac artery was noted.The complaint is most likely user-related; an abdominal aortic aneurysm was not present and therefore, this is off-label use of the product.Procedure related harms for this complaint could not be determined.The final patient status was reported to be doing well post 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.(b)(4).
Event or Problem Description
Additional information received per clinical assessment confirming that left leg ischemia, stent buckling, and stenosis and thrombus of the right common iliac artery are included in the reported event.In addition, clinical determined that an abdominal aortic aneurysm was not present for the patient and therefore, the afx2 product was an off-label use.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7777049
• Report Number: 2031527-2018-00661
• Device Sequence Number: 19280998
• Product Code: MIH
• UDI-Device Identifier: 00818009015075
• UDI-Public: (01)00818009015075(17)181019
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2018

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: Health Professional
• Device Expiration Date: 10/19/2018
• Device Model Number: BEA22-40/I13-40
• Device Lot Number: 1751278-004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/21/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 10/17/2018
• 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: 57 YR