MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C80-O20 V
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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 a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, a type 1a endoleak, migration and sac growth were discovered during a routine follow up.This event was resolved by implanting a suprarenal stent graft extension and a infrarenal stent graft extension this event was previously reported under 2031527-2019-00254.Approximately three (3) months post re- intervention, a type 2 endoleak was discovered during a routine follow up.A type 2 endoleak is not a device related failure therefore no further details were provided.Approximately five (5) years post initial procedure, another type 1a and sac growth was identified.This event was resolved by implanting a suprarenal stent graft extension and a limb stent graft extension.This event was previously reported under 2031527-2020-00263.During the investigation of the previous reported events, it was identified that the patients anatomy is outside the indications of use (off- label) due to the infrarenal angulation of 55°.Now, approximately 2 months post the re- intervention, another 1a endoleak has occurred.The patient is currently being monitored as another intervention is being planned.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.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.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 persistent type 1a endoleak was confirmed.This is consistent with the reported adverse event/incident.The most likely causation for the type 1a endoleak is most likely user related due to the off-label nature of the pre-index neck anatomy (63 degrees should be less than or equal to 60 degrees).The final patient status was reported to be under surveillance pending an additional 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.Corrections: g4: date of received by manufacturer.H6 device code; remove 3190.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10885453
• Report Number: 2031527-2020-00346
• Device Sequence Number: 3007370
• Product Code: MIH
• UDI-Device Identifier: 00818009013606
• UDI-Public: (01)00818009013606(17)230422
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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: 04/22/2023
• Device Model Number: A34-34/C80-O20 V
• Device Lot Number: 2348739007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 01/26/2021
• 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 1342797-014; AFX LIMB STENT GRAFT 2010411002; AFX VELA INFRARENAL VELA INFRARENAL 1936674004; AFX VELA SUPRARENAL 1341524-014; AFX VELA SUPRARENAL 2237686007; AFX BIFURCATED STENT GRAFT 1342797-014; AFX LIMB STENT GRAFT 2010411002; AFX VELA INFRARENAL VELA INFRARENAL 1936674004; AFX VELA SUPRARENAL 1341524-014; AFX VELA SUPRARENAL 2237686007
• Outcome Attributed to Adverse Event: Other