MAUDE Adverse Event Report: ENDOLOGIX AFX; AFX2 BIFURCATED STENT GRAFT

Model Number BEA25-100/I16-40

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 12/02/2020

Event Type  Injury  

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.

Event Description

The patient was initially implanted with an afx2 bifurcated stent graft to treat an abdominal aortic aneurysm (aaa).Approximately 2 years post initial procedure and during a routine visit the radiologist identified a 2mm aneurysm growth (insignificant due to less than 5mm), a type 2 endoleak (anatomy-related), and a suspected implant movement (unknown distance) on the computed tomography (ct).Re-intervention was completed and the physician elected to place a vela suprarenal proximal extension on (b)(6) 2020.No endoleak was noted post procedure and the patient is stable.

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 main body migration as unconfirmed due to a lack of comparative imaging and the reported type 2 endoleak was identifed to be a type 1a endoleak.This is not consistent with the reported adverse event/incident.Procedure-related harms, device, user, procedure, or anatomy relatedness of this complaint could not be determined with the medical records available for review.The final patient status was reported as being stable post-secondary endovascular procedure.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.

Event Description

The patient was initially implanted with a afx 2 bifurcated stent graft to treat an abdominal aortic aneurysm (aaa).Approximately 2 years post initial procedure during a routine visit the radiologist identified a 2mms aneurysm growth, and a type 2 endoleak on the computed tomography (ct).Re-intervention complete the physician elected to place a vela suprarenal proximal extension to the renal arteries.No endoleak post procedure per physician.Patient is stable.Additional information: clinical assessment determined that the reported type ii endoleak was identified as type 1a endoleak from medical records.

• Brand Name: AFX
• Type of Device: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11091988
• MDR Text Key: 224252133
• Report Number: 2031527-2020-00384
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014726
• UDI-Public: (01)00818009014726(17)190605
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2019
• Device Model Number: BEA25-100/I16-40
• Device Lot Number: 1943042007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR