MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA25-100/I16-40

Device Problems Material Puncture/Hole (1504); Insufficient Information (3190)

Patient Problems Aneurysm (1708); Cardiopulmonary Arrest (1765); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Respiratory Failure (2484)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

The device remains implanted in the patient; therefore, it 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 duraply.

Event Description

The patient was initially implanted with afx bifurcated stent graft, an afx vela infrarenal and an afx vela suprarenal to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, a possible type iiib endoleak.Patient is stable and re-intervention is to be scheduled.

Manufacturer Narrative

The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, the type iiib endoleak of the distal bifurcated stent graft event is confirmed.The clinical assessment determined that there was evidence to reasonably suggest sac growth of 5.5mm had occurred.Procedure related harms, device, user, procedure or anatomy relatedness of this event could not be determined with the medical record/ images available for review.The final patient status was not reported.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx with duraply.Corrections: h6: device remove code 3190.H6: result remove code 3233.H6: conclusion remove code 11.

Event Description

The patient was initially implanted with afx bifurcated stent graft, an afx vela infrarenal and an afx vela suprarenal to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, a possible type iiib endoleak.Patient is stable and re-intervention is to be scheduled.Additional information: during clinical assessment it was determined that there was evidence to reasonably suggest sac growth of 5.5mm had occurred.Also, the patient is stable and waiting for an intervention.The intervention has been postponed due to covid-19.

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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.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 the type iiib endoleak of the distal bifurcated stent graft event is confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest sac growth of 5.5mm had occurred.These findings were discovered during an examination of the post implant computed tomography (ct) scan dated (b)(6) 2020.The most likely causation for the type iiib endoleak is indeterminate.Procedure related harms include acute blood loss, rupture, hypoxic respiratory failure, cardiac arrest, and hemodynamic instability.The final patient status was reported as being discharged home on (b)(6) 2020 with physical therapy and nursing support due to a debilitated condition.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 duraply.

Event Description

The patient was initially implanted with an afx bifurcated stent graft, a vela infrarenal stent graft and a vela suprarenal stent graft to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, a type iiib endoleak and sac growth of 5.5mm was identified.On (b)(6) 2020 the patient underwent a transcatheter aortic valve replacement (tavr) procedure prior to the re-intervention to resolve the 3b endoleak.The physician relined the existing stent grafts with an afx2 bifurcated stent graft and the endoleak was resolved.Subsequently, the patient suffered a retroperitoneal hemorrhage bleed and respiratory failure unrelated to the device.The patient was resuscitated and is expected to fully recover.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10196425
• MDR Text Key: 199986206
• Report Number: 2031527-2020-00180
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009010032
• UDI-Public: (01)00818009010032(17)180630
• 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: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2020

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: 06/30/2018
• Device Model Number: BA25-100/I16-40
• Device Lot Number: 1252307010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 05/27/2020; 01/22/2021
• Supplement Dates FDA Received: 08/14/2020; 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0006-2019
• Patient Sequence Number: 1
• Treatment: AFX VELA INFRARENAL (LN 1252187009); AFX VELA SUPRARENAL (LN 1252417050)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 77 YR