MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA22-90/I16-30

Device Problems Off-Label Use (1494); Patient-Device Incompatibility (2682); Migration (4003); Separation Problem (4043)

Patient Problem Aneurysm (1708)

Event Date 02/07/2024

Event Type  Injury  

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx vela suprarenal aortic extension.It was noted that the proximal neck angle was over 60 degrees which is considered to be off-label.It was also noted that there was adequate overlap of three (3) stent lengths at the initial procedure.Approximately four (4) years post initial procedure, during routine follow-up shortening of the overlap between the afx2 and vela was observed and one (1) stent length of overlap remained.Additionally, there was sac enlargement of approximately 5mm.The physician elected to implant two additional afx vela suprarenal aortic extensions on (b)(6) 2024 to successfully resolve this event.The final angiogram showed there was no endoleak and the patient was reported as stable post this secondary procedure.

Manufacturer Narrative

The device involved in this 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 afx2 h3 other text: device remains implanted.

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.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 type 3a endoleak between the bifurcated stent graft and the vela suprarenal cuff, and the aneurysm enlargement of 13.1mm are confirmed.The additional endovascular procedure is unconfirmed.This is moderately consistent with the reported adverse event/incident.The clinical assessment also determined migration of 5.6 mm of the proximal extension occurred that was not in the event as reported.The migration was discovered during a review of the computed tomography (ct) scan dated (b)(6) 2024.The complaint is most likely user and anatomy related.The infrarenal angle at index was off label at 62° (should be equal to or less than 60°).The infrarenal angulation increased from 62° to 71.6°.This likely contributed to the reported type 3a component separation (aortic remodeling/anatomy).The proximal extension was in suboptimal position on the ct scan dated (b)(6) 2020.Migration of 5.6 mm was noted on the ct scan of (b)(6) 2024, this did not appear to contribute to the reported event.Procedure related harms for this complaint could not be identified.The final patient status was reported as 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 afx2.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: 18818448
• MDR Text Key: 336739953
• Report Number: 3011063223-2024-00028
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/13/2024

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: 04/11/2021
• Device Model Number: BEA22-90/I16-30
• Device Lot Number: 2240019008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 03/23/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0007-2019
• Patient Sequence Number: 1
• Treatment: AFX VELA SUPRARENAL, LOT # 2276852006.
• Patient Outcome(s): Required Intervention