MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A28-28/C75-O20V
Medical Device Problem Codes	Use of Device Problem (1670); Unintended Movement (3026)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Pain (1994); Rupture (2208)
Date of Event	11/24/2020
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 duraply.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and a vela suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately sixteen (16) days post initial procedure, the patient presented emergently with back pain, nausea and vomiting.A computed tomography (ct) revealed the proximal extension had slipped down (migrated) causing aneurysm growth and a rupture.The physician treated this event by implanting another vela suprarenal stent graft extension.The patient was reported as being stable post intervention.
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 the migration of the proximal extension of 20mm, sac growth of 26.5mm, and rupture were confirmed.This is consistent with the reported adverse event/incident.The most likely causation for this event is user related due to the use of a 28mm proximal extension with a 28 mm bifurcated stent is not recommended (proximal extension should be one size larger than the bifurcated main body stent).Also the patient was ruptured prior to the index procedure; this is a cautionary product use condition.The final patient status was reported as being stable post-secondary intervention.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.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11024343
• Report Number: 2031527-2020-00374
• Device Sequence Number: 19719965
• Product Code: MIH
• UDI-Device Identifier: 00818009013583
• UDI-Public: (01)00818009013583(17)220511
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 11/25/2020

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: 05/11/2022
• Device Model Number: A28-28/C75-O20V
• Device Lot Number: 2247414010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/18/2021
• 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: AFX2 BIFURCATED STENT GRAFT, LOT# 2285394006; AFX2 BIFURCATED STENT GRAFT, LOT# 2285394006
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR