MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A28-28/C95-O20V
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a 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 treated for an abdominal aortic aneurysm (aaa) with the afx2 bifurcated stent graft and afx vela suprarenal stent graft.Approximately (3) three years after post initial procedure, the patient presented with an aneurysm sac enlargement however an endoleak was not identified with an angiogram.It was noted that the afx vela suprarenal stent graft was a few millimeters below the renal artery, but still no endoleak present.As a pre-caution, the physician elected to treat the patient by re-lining the originally implanted devices with another afx2 bifurcated stent graft and an afx vela suprarenal stent graft.The re-intervention procedure was successful.The final patient status was reported as doing great.
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.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 the aneurysm enlargement of 23mm and additional endovascular procedure adverse event/incident(s) are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest two other endovascular procedures occurred that were not included in the event as reported: in march of 2020 a type ii endoleak (non-device related failure) was coiled from the lumbar artery and on 10/08/2020 another type ii endoleak (non-device related failure) was coiled in the sacral artery.These findings were discovered during an examination of the 41-month post-index discharge summary.Procedure related harms, device, user, procedure or anatomy relatedness of the aneurysm enlargement could not be determined with the medical records available for review.The final patient status was reported as being discharged on the first postoperative day home 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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 bifurcated stent graft and afx vela suprarenal stent graft.Approximately (3) three years after post initial procedure, the patient presented with an aneurysm sac enlargement however an endoleak was not identified with an angiogram.It was noted that the afx vela suprarenal stent graft was a few millimeters below the renal artery, but still no endoleak present.As a pre-caution, the physician elected to treat the patient by re-lining the originally implanted devices with another afx2 bifurcated stent graft and an afx vela suprarenal stent graft.The re-intervention procedure was successful.The final patient status was reported as doing great.Subsequent to the initial report, clinical assessment determined that there was evidence to reasonably suggest two other endovascular procedures occurred that were not included in the event as reported: in march of 2020 a type ii endoleak (non-device related failure) was coiled from the lumbar artery and on (b)(6) 2020 another type ii endoleak (non-device related failure) was coiled in the sacral artery.These additional endovascular procedures were discovered during a review of the 41-month post-index discharge summary.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; ,; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; ,; irvine, CA 92618 ; 8009832284
• MDR Report Key: 12858246
• Report Number: 2031527-2021-00470
• Device Sequence Number: 19985596
• Product Code: MIH
• UDI-Device Identifier: 00818009013637
• UDI-Public: (01)00818009013637(17)201214
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2021

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: 12/14/2020
• Device Model Number: A28-28/C95-O20V
• Device Lot Number: 1767695003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX2 BIFURCATED STENT GRAFT 1927436001
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Unknown