MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-110/I16-30
Medical Device Problem Codes	Use of Device Problem (1670); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx2.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately 2.5 years post initial procedure, the patient presented emergently with back pain.A type 3a endoleak between the bifurcated devices and proximal extension was identified by computed tomography (ct) scan.An intervention was completed.The physician elected to implanted a suprarenal stent graft extension and an infrarenal stent graft extension to resolve to event.The patient was reported as stable post- intervention.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, the reported type 3a endoleak of the aortic components was confirmed.The issue is most likely anatomy /user related due to incorrect sizing of the proximal extension, rupture occurred prior to the index procedure and infrarenal angle increased from 30 to 67 degrees and 75 degrees from the bifurcation to the left common iliac artery respectively (aortic remodeling).No procedure related harms were identified.The final patient status was discharged home stable.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Corrections: b5: describe event or problem.H6: device code: remove code 3190.H6: results code: remove code 3233.H6: conclusion code: remove code 11.Device iteration is afx2.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9929752
• Report Number: 2031527-2020-00128
• Device Sequence Number: 2764288
• Product Code: MIH
• UDI-Device Identifier: 00818009014856
• UDI-Public: (01)00818009014856(17)180320
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2020

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: 03/20/2018
• Device Model Number: BEA25-110/I16-30
• Device Lot Number: 1668198-003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2020
• Supplement Date Received by Manufacturer: 03/08/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VELA SUPRARENAL, LOT 1679304-023
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR