MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-90/I16-30
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Endologix will continue to investigate the reported event.The patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.
Event or Problem Description
An afx bifurcated stent graft system was implanted to treat an abdominal aortic aneurysm.The patient presented to the er with abdominal pain approximately 3.5 years post index procedure.A ct was performed where a potential type iiia endoleak was observed.The physician has elected to perform a re-intervention to reline the afx graft, however, the date of re-intervention has not been scheduled.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
Based on the information received, clinical evaluation confirmed the urgent presentation, type iiia endoleak, complete aortic component separation and secondary endovascular procedure.Device, user, procedure or anatomy relatedness of this complaint could not be determined based on the information shared with endologix to review.The final patient status was in stable condition post secondary endovascular procedure.A definitive root cause for the reported event could not be determined.The devices remain implanted in the patient and will not be returned; therefore, device evaluation will not be completed.The review of manufacturing lot confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.
Event or Problem Description
Additional information was received reporting that on 03/06/2018, the secondary procedure was performed.Reportedly, it was confirmed, there was no leak and no sac growth, just minimal overlap of the previously implanted stents.The physician elected to add a vela suprarenal cuff and a vela infrarenal cuff to improve overlap.The patient was discharged the next day and was reported to be pain free and in good condition.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7392173
• Report Number: 2031527-2018-00211
• Device Sequence Number: 11116924
• Product Code: MIH
• UDI-Device Identifier: 00818009010247
• UDI-Public: (01)00818009010247(17)170814
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

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: Health Professional
• Device Expiration Date: 08/14/2017
• Device Model Number: BA28-90/I16-30
• Device Lot Number: 1268463027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 06/29/2018
• 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 INFRARENAL: A34-34/C80 V; AFX VELA INFRARENAL: A34-34/C80 V
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR