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	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the 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 strata.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft and a suprarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately two and a half (2.5) years later, aneurysm growth, stent movement, and a type 3a endoleak were identified.The physician completed an intervention on (b)(6) 2016, and elected to implant an infrarenal aortic extension to treat this event.This was reported on mdr# 2031527-2016-00580.Now, approximately six and a half (6.5) years post initial procedure during a routine follow up, a new type 3a endoleak was identified, and the originally implanted suprarenal aortic extension has expanded outside the infrarenal aortic extension.The patient is currently being monitored.
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.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted in patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the type 3a endoleak (aortic) was confirmed.This is consistent with the reported adverse event/incident.The most likely causation for the type 3a endoleak was due the incorrect size of the stents.The vela suprarenal (proximal) stent graft was 34mm and was implanted with a 25mm bifurcated stent graft (off-label condition)).The final patient status was reported as recovering well after 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.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft and a suprarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately two and a half (2.5) years later, aneurysm growth, stent movement, and a type 3a endoleak were identified.The physician completed an intervention on (b)(6) 2016 , and elected to implant an infrarenal aortic extension to treat this event.This was reported on mdr# 2031527-2016-00580.Now, approximately six and a half (6.5) years post initial procedure during a routine follow up, a new type 3a endoleak was identified, and the originally implanted suprarenal aortic extension has expanded outside the infrarenal aortic extension.The patient is currently being monitored.Additional information: a re-intervention was completed.The physician elected to treat the patient by implanting a afx2 bifurcated stent graft and a vela suprarenal.The type 3a endoleak was resolved and the final patient status was reported as doing well.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10645640
• Report Number: 2031527-2020-00284
• Device Sequence Number: 3248715
• Product Code: MIH
• UDI-Device Identifier: 00818009013606
• UDI-Public: (01)00818009013606(17)141214
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/14/2014
• Device Model Number: A34-34/C80-O20 V
• Device Lot Number: 1203998014
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 12/09/2020
• 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: BIFURCATED STENT GRAFT, LOT# 1136113-010; VELA INFRARENAL, LOT 1604744014
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 81 YR