MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C80-O20 V
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Separation Problem (4043)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	09/10/2020
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 afx with duraply.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).It was reported that this initial case was off-label per sizing report.Approximately four (4) years post initial procedure during a routine follow up, it was discovered that the aneurysm had continued to grow in a lateral fashion and has displaced the aortic extension identifying as a 3a endoleak.Re-intervention was completed and an additional one (1) afx2 bifurcated stent graft with two (2) aortic extensions were implanted on (b)(6) 2020.Patient status was reported as doing well.
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.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.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 a type iiia endoleak of the aortic components with complete component separation is confirmed.However, the sac growth is unconfirmed due to a lack of comparative medical imaging.Device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.No procedure-related harms were identified.During the investigation and with the information available, endologix found no evidence to suggest the device was used off-label.The final patient status was reported as discharged on the third post-operative day following a successful 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 duraply.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).It was reported that this initial case was off-label per sizing report.Approximately four (4) years post initial procedure during a routine follow up, it was discovered that the aneurysm had continued to grow in a lateral fashion and has displaced the aortic extension identifying as a 3a endoleak.Re-intervention was completed and an additional one (1) afx2 bifurcated stent graft with two (2) aortic extensions were implanted on (b)(6) 2020.Patient status was reported as doing well.Additional information received per clinical assessment confirming that the secondary procedure was an off-label case based on procedure planning dated (b)(6) 2020; clinical evaluation is unable to determine if the index case was also off-label.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10621156
• Report Number: 2031527-2020-00280
• Device Sequence Number: 19531274
• Product Code: MIH
• UDI-Device Identifier: 00818009013606
• UDI-Public: (01)00818009013606(17)190608
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 09/11/2020

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: 06/08/2019
• Device Model Number: A34-34/C80-O20 V
• Device Lot Number: 1484364008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 11/23/2020
• 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-0008-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX2 BIFURCATED STENT GRAFT 1354926020; AFX2 BIFURCATED STENT GRAFT 1354926020
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR