MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number A28-28/C95-O20V

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 10/12/2021

Event Type  Injury  

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 Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with an afx2 bifurcated stent graft and an afx vela suprarenal proximal extension.Approximately one and a half (1.5) months post initial procedure, the patient presented at routine follow-up with a type ia endoleak due to distal movement of the proximal extension, and a type ib endoleak.The physician elected to treat the patient by implanting an additional afx vela suprarenal with an ovation ix extender on (b)(6) 2021.The endoleaks were successfully resolved and the patient is reportedly in stable condition.

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 could not be completed.No medical records nor medical imaging relevant to the reported adverse event/incident was received by endologix.The user facility was unable to provide this information.Due to the absence of medical records and medical imaging; device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.The final patient status was reported as being in stable condition.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: h6: investigation finding codes : remove code 3233.H6: investigation conclusion codes: remove code 11.

• Brand Name: AFX
• Type of Device: 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: 12720327
• MDR Text Key: 279056344
• Report Number: 2031527-2021-00455
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009013637
• UDI-Public: (01)00818009013637(17)231029
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2023
• Device Model Number: A28-28/C95-O20V
• Device Lot Number: 2398305-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AFX BIFURCATED STENT GRAFT, SN (B)(6). ; AFX BIFURCATED STENT GRAFT, SN (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR