MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA25-90/I16-30

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem Failure of Implant (1924)

Event Date 04/12/2023

Event Type  malfunction  

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft.During the initial implant procedure, the contralateral wire was noted to be twisting around the delivery system of the bifurcated stent graft.The physician then rotated the delivery system in both directions, however the stent graft did not seem to rotate with the handle rotation.Therefore, the physician pulled the contralateral wire, after which its orientation appeared as resolved.The delivery system was then seated on the terminal aorta and the control cord pulled for stent graft deployment.A strong resistance was felt, so the delivery system was rotated again and the control cord pulled a second time.The bifurcated stent graft then successfully deployed.Resistance was felt again while retrieving the control cord and main body cover, and it was discovered that the distal portion of the cover was torn and detached from the control cord.Only the cord with a metal part originally attached to the red cover were retrieved from the patient's body.The operation was continued as planned and an afx vela infrarenal implanted, final angiography did not visualize the torn cover, therefore it was considered to be pinched between the bifurcated stent graft and aneurysm wall.The delivery system and control cord are not available for return/evaluation.

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.H3 other text : devices not returned.

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.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the reported afx2, intraoperative contralateral wire twisted (difficult to advance), difficult to deploy main body, difficult to remove control cord and main body cover, and delivery system detachment (main body cover not retrieved) are unconfirmed.This is not consistent with the reported adverse event/incident.Procedure-related harms, device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.The final patient status was not reported.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.Corrections: g3 awareness date h6 investigation finding codes; remove 3233 h6 investigation conclusion codes; remove 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: 16892331
• MDR Text Key: 315095857
• Report Number: 2031527-2023-00156
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014863
• UDI-Public: (01)00818009014863(17)250914
• 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: 04/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEA25-90/I16-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• 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): Other