MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A25-25/C95-O20 V
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	06/12/2020
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 strata.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft and an afx vela suprarenal to treat an abdominal aortic aneurysm (aaa).Approximately, six years post initial procedure, routine follow-up computerized tomography identified aneurysm enlargement of 8cm and ~20mm migration of the vela suprarenal.Reportedly, the lumber and inferior mesenteric arteries are patent.The patient is being monitored.Re-intervention has not yet been scheduled.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft and an afx vela suprarenal to treat an abdominal aortic aneurysm (aaa).Approximately, six years post initial procedure, routine follow-up computerized tomography identified aneurysm enlargement of 8cm and ~20mm migration of the vela suprarenal.Reportedly, the lumber and inferior mesenteric arteries are patent.The patient is being monitored.Re-intervention has not yet been scheduled.Additional information: during clinical assessment, it was determined that the patient underwent a secondary procedure and was discharged on (b)(6) 2020 post procedure (date of actual procedure unknown) upon reviewing the patient's discharge summary report.
Additional Manufacturer Narrative
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.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that the proximal extension migration, sac growth and type ii endoleak events are unconfirmed.Procedure related harms, device, user, procedure or anatomy relatedness of this event could not be determined with the medical records available for review.The final patient status was discharged home on the first postoperative day following a secondary endovascular procedure.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 strata.Corrections: b2: outcomes attributed to adverse events has been updated.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: 10330643
• Report Number: 2031527-2020-00221
• Device Sequence Number: 13659452
• Product Code: MIH
• UDI-Device Identifier: 00818009013620
• UDI-Public: (01)00818009013620(17)141211
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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: 12/11/2014
• Device Model Number: A25-25/C95-O20 V
• Device Lot Number: 1203047007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 09/28/2020
• 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 1066412-002)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 81 YR