MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA25-90/I16-30

Device Problems Material Puncture/Hole (1504); Material Integrity Problem (2978)

Event Date 07/13/2023

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 afx with strata h3 other text : device remains implanted.

Event Description

The patient was initially implanted with an afx bifurcated stent graft and an afx vela infrarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately nine (9) years post initial procedure, a type 3b endoleak was identified on an unknown date.The physician elected to reline the original implanted devices with an afx2 bifurcated stent graft to successfully resolved the type 3b endoleak.The final patient status after this intervention was reported as doing okay.Exact date of event was not provided; therefore, best estimated date was selected.

Event Description

The patient was initially implanted with an afx bifurcated stent graft and an afx vela infrarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately nine (9) years post initial procedure, a type 3b endoleak was identified on an unknown date.The physician elected to reline the original implanted devices with an afx2 bifurcated stent graft to successfully resolved the type 3b endoleak.The final patient status after this intervention was reported as doing okay.Exact date of event was not provided; therefore, best estimated date was selected.Additional information: an internal clinical assessment determined that there was evidence to reasonably suggest a type 3a endoleak of the aortic components occurred that was not included in the event as reported.The type 3a endoleak was discovered during a review of the computed tomography (ct) scan labeled "post".

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 3b endoleak of the bifurcated stent graft and the additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The clinical assessment also shows reasonable evidence to suggest a type 3a endoleak of the aortic components occurred that was not included in the event as reported.The type 3a endoleak was discovered during a review of the computed tomography (ct) scan labeled "post".The type 3b endoleak is most likely device related due to the use of strata material.The cause of the type 3a endoleak could not be determined.Procedure related harms for this complaint could not be determined.The final patient status was reported as doing okay.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type iiib endoleak.Endologix implemented the following corrective actions with the intent of reducing type iiib endoleak events; 1.Upgraded graft material (i.E.Duraply) and 2.Updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place july 2014.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 strata corrections: b5: describe event or problem has been updated g3: awareness date has been updated h6: investigation finding codes: remove code 3233 h6: investigation conclusion codes: remove code 11.

• Brand Name: AFX
• 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: 17419740
• MDR Text Key: 320017964
• Report Number: 2031527-2023-00192
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: BA25-90/I16-30
• Device Lot Number: 1053225-014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 07/28/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2013
• 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-0006-2019
• Patient Sequence Number: 1
• Treatment: AFX INFRARENAL AORTIC EXTENSION, LOT # 1046904-017
• Patient Outcome(s): Required Intervention