MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA28-80/I16-40

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

Patient Problems Aneurysm (1708); Failure of Implant (1924)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft and an afx suprarenal aortic extension.Approximately two (2) years post initial procedure, follow up computed tomography revealed a distal endoleak.The distal endoleak was successfully treated with implant of an additional afx limb stent extension.Reportedly, the patient tolerated the procedure well.This event was previously reported under mfr# 2031527-2014-00055.Approximately five (5) years post reintervention, a type 3b endoleak was identified.Reintervention was completed with implant of a gore (non-endologix) stent.Patient status was not reported at the time.Now, approximately three (3) years post-re-intervention, during a routine follow up a type 2 endoleak (non-device related) and aneurysm enlargement were identified.Approximately nine (9) months later the physician elected to perform an open repair and explanted the stent grafts.The patient was reported as stable post the open repair.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft and an afx suprarenal aortic extension.Approximately two (2) years post initial procedure, follow up computed tomography revealed a distal endoleak.The distal endoleak was successfully treated with implant of an additional afx limb stent extension.Reportedly, the patient tolerated the procedure well.This event was previously reported under mfr# 2031527-2014-00055.Approximately five (5) years post reintervention, a type 3b endoleak was identified.Reintervention was completed with implant of a gore (non-endologix) stent.Patient status was not reported at the time.Now, approximately three (3) years post-re-intervention, during a routine follow up a type 2 endoleak (non-device related) and aneurysm enlargement were identified.Approximately nine (9) months later the physician elected to perform an open repair and explanted the stent grafts.The patient was reported as stable post the open repair.Clarification: the patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft and an afx suprarenal aortic extension.Approximately two (2) years post initial procedure, follow-up computed tomography revealed a distal endoleak (classified as a type 1b endoleak).The distal endoleak was successfully treated with implant of an afx limb stent graft extension on (b)(6) 2014.Reportedly, the patient tolerated the procedure well.This event was previously reported under mfr.Report # 2031527-2014-00055.Approximately three (3) years post secondary intervention, a type 3b endoleak was identified.Tertiary intervention was completed with implant of a gore (non-endologix) stent on (b)(6) 2017.Patient status was not reported at the time.This mdr (medical device report) is to address the type 3b endoleak event that was recently identified by endologix when reviewing a recent non-reportable event.Additional information identified per clinical assessment: there was evidence to reasonably suggest significant aneurysm sac growth also occurred at the time of the event.Note: the recent non-reportable event was for a type 2 endoleak (non-device related) and aneurysm enlargement that occurred approximately four (4) years post tertiary procedure, a type 2 endoleak (non-device related) and aneurysm enlargement were identified during a routine follow-up.The physician elected to perform an open repair and explant the stent grafts on (b)(6) 2021.The patient was reported as stable post open repair.This quaternary intervention is not a reportable event as type 2 endoleaks are anatomy-related and not related to a failure of the device.

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 was not completed.The device was not returned to endologix for evaluation because it remains implanted per 2017 event.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 type 3b endoleak (to the distal portion of the bifurcated stent graft) and additional endovascular procedure on (b)(6) 2017 are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest sac growth (of 9.3mm) occurred that was not included in the event as reported.This finding was discovered during an examination of the 57-month post operative note.The most likely causation for the reported event is device-related due to use of strata material.No procedure-related harms could be determined with the medical records available for review.The final patient status was reported as discharged at home on the first post operative day in stable condition.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; 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 (b)(6) 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.

• 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: 13114827
• MDR Text Key: 283759648
• Report Number: 2031527-2021-00510
• Device Sequence Number: 1
• Product Code: MIH
• 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: 12/20/2021

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: 12/31/2012
• Device Model Number: BA28-80/I16-40
• Device Lot Number: 1028670-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 03/16/2022
• Supplement Dates FDA Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2012
• 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 ILIAC LIMB STENT GRAFT, LOT # 1047167-007; AFX SUPRARENAL EXTENSION, LOT # W11-4679-006; GORE (NON-ENDOLOGIX) STENTS, LOT # UNKNOWN; ILIAC LIMB STENT GRAFT, LOT # 1047167-007; SUPRARENAL EXTENSION, LOT # W11-4679-006
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male