MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A28-28/C95-O20
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Separation Problem (4043)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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 afx with duraply.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft and an afx suprarenal stent graft to treat an abdominal aortic aneurysm (aaa).Approximately 2.5 years post initial procedure during routine follow-up a type 3a endoleak with device separation.Re-intervention was performed by bridging the index devices with implant and an afx vela suprarenal.Reportedly, the proximal neck just below the renal artery was dilated and the vessel was not in good condition.The afx vela suprarenal migrated slightly during deployment.The junction was sealed; however, it was decided to add an additional afx vela suprarenal.The re-intervention was completed without any endoleaks.The patient post procedure was stable.
Additional Manufacturer Narrative
An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that a type iiia endoleak of the aortic components with complete separation event is confirmed.Procedure related harms, device, user, procedure or anatomy relatedness of this event could not be determined with the medical record/ images available for review.The final patient status was reported to be stable.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.Device iteration is afx with duraply.Corrections: h6: method remove 3233.H6: conclusion remove 11.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10271725
• Report Number: 2031527-2020-00194
• Device Sequence Number: 19033458
• Product Code: MIH
• UDI-Device Identifier: 00818009010391
• UDI-Public: (01)00818009010391(17)190729
• Combination Product (Y/N): N
• 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,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2019
• Device Model Number: A28-28/C95-O20
• Device Lot Number: 1535931-019
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 09/07/2020
• 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 BIFURCATED STENT GRAFT (LN 1297653029); AFX BIFURCATED STENT GRAFT (LN 1297653029)
• Outcome Attributed to Adverse Event: Required Intervention