MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA25-90/I20-30

Device Problem Insufficient Information (3190)

Patient Problems Respiratory Failure (2484); Insufficient Information (4580)

Event Date 07/26/2023

Event Type  Injury  

Event Description

The patient received treatment for an abdominal aortic aneurysm (aaa) through the implantation of an afx2 bifurcated stent graft and an afx vela suprarenal device.Approximately one (1) day following the initial procedure, the patient presented with symptoms of back pain and experienced renal occlusion.A computerized tomography (ct) scan was conducted, which confirmed proper blood flow to the renal area.Later that day, it was reported that the patient necessitated a surgical conversion, during which the afx vela suprarenal device was explanted (manufacturer report number 2031527-2023-00189).The patient was reportedly discharged on (b)(6), 2023.A clinical assessment revealed that an additional endovascular procedure also took place, involving the placement of a fenestrated graft on (b)(6), 2023.This supplementary intervention's discovery was based on a comprehensive review of the operative report dated (b)(6), 2023 and discharge summary dated (b)(6), 2023.It was reported that the graft had been extended with a fenestrated cuff.The final patient status was reported as stable post-intervention.No additional information is currently available regarding this initial report.This report is to address the re-intervention event on (b)(6), 2023.

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation.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 afx2.

Manufacturer Narrative

The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix's 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.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 afx2 additional endovascular procedure complaint is confirmed.This is consistent with the reported adverse event/incident.The complaint is most likely procedure-related.The procedure-related harm identified was a pulmonary embolism.The pseudoaneurysm is likely caused by the surgical conversion with an explant of the suprarenal cuff done to alleviate renal artery occlusion on (b)(6) 2023.The additional endovascular procedure (fenestrated graft) was done to exclude the pseudoaneurysm.The final patient status was reported as discharged home on postoperative day four.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: g3: awareness date ¿ updated.H6: health effect clinical code - remove code 4580.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

• Brand Name: AFX2
• Type of Device: BIFURCATED STENT GRAFT
• 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: 17944305
• MDR Text Key: 325801592
• Report Number: 3011063223-2023-00012
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014825
• UDI-Public: (01)00818009014825(17)230910
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2023
• Device Model Number: BEA25-90/I20-30
• Device Lot Number: 2383792006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male