MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA28-90/I16-30

Device Problems Complete Blockage (1094); Patient-Device Incompatibility (2682); Device-Device Incompatibility (2919)

Patient Problems Death (1802); Thrombus (2101)

Event Date 12/07/2020

Event Type  Death  

Manufacturer Narrative

The device involved in the 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 a bifurcated stent graft and a vela suprarenal extension to treat an abdominal aortic aneurysm (aaa).Approximately 35-40 minutes into the case, a clot (thrombus) was noticed and heparin was administered.While the bifurcated device and proximal extension were implanted with no issues, thrombus was again noted in the aortic body and right limb of the stent grafts after ballooning.The physician used a 4mm balloon to extract the thrombus in the limb, but the patient still did not have pulses in either leg (classified as occlusion).Physician planned to go back in radially with a long sheath, however the patient then coded, cpr (cardiopulmonary resuscitation) was administered and the patient subsequently expired.Note: during the initial implant procedure, the patient had a minor dissection in the aorta, but this was reportedly sealed.

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 aortic and limb thrombus complaints are unconfirmed.This is not consistent with the reported adverse event/incident.The most likely causation for thrombosis and death is due to the off label conditions of the following; patient's severe and pre-existing peripheral arterial disease with previously placed bilateral iliac stents that were moderately stenosed at the time of the index procedure and for an abdominal aortic aneurysm (aaa) not being present.It was noted heparin was not administered until 35-40 minutes into the case.The patient death was determined to be procedure and user related.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: b5: describe event or problem has been updated.G1/g2: contact office - name has been updated.G4: date received by manufacturer has been updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

Event Description

The patient was initially implanted with a bifurcated stent graft and a vela suprarenal extension to treat an abdominal aortic aneurysm (aaa).Approximately 35-40 minutes into the case, a clot (thrombus) was noticed and heparin was administered.While the bifurcated device and proximal extension were implanted with no issues, thrombus was again noted in the aortic body and right limb of the stent grafts after ballooning.The physician used a 4mm balloon to extract the thrombus in the limb, but the patient still did not have pulses in either leg (classified as occlusion).Physician planned to go back in radially with a long sheath, however the patient then coded, cpr (cardiopulmonary resuscitation) was administered and the patient subsequently expired.Note: during the initial implant procedure, the patient had a minor dissection in the aorta, but this was reportedly sealed.Additional information: during the investigation it was determined that a aaa was not present at the time of the index procedure which is considered an off label condition.

• Brand Name: AFX2
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11102220
• MDR Text Key: 224594548
• Report Number: 2031527-2020-00387
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014597
• UDI-Public: (01)00818009014597(17)230519
• 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: 12/07/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2023
• Device Model Number: BEA28-90/I16-30
• Device Lot Number: 2355326006
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VELA SUPRARENAL, LOT # 2378440009; VELA SUPRARENAL, LOT # 2378440009
• Patient Outcome(s): Death
• Patient Age: 59 YR