MAUDE Adverse Event Report: ENDOLOGIX AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number BEA22-40/I13-40

Device Problems Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906); Device-Device Incompatibility (2919)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Failure of Implant (1924); Blood Loss (2597)

Event Date 09/15/2020

Event Type  Death  

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it was explanted but disposed of by the facility.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 physician was implanting an afx2 bifurcated stent graft to treat the patient for an abdominal aortic aneurysm (aaa).Reportedly, during the procedure the pull through wire was wrapped around the graft and the stent became crossed inside the aorta and partially deployed.The physician was unable to straighten the wire to see the graft in the bifurcation of the iliacs.The physician elected to abort the stent graft placement and converted to an open procedure to explant the graft.The stent graft was explanted successfully, and the physician completed a repair with a non-endologix aorto-bi-femoral dacron graft.Post procedure, the patient was transferred to intensive care unit (icu), intubated, and later expired.The device will not be returned as it was disposed of by the facility.

Event Description

The physician was implanting an afx2 bifurcated stent graft to treat the patient for an abdominal aortic aneurysm (aaa).Reportedly, during the procedure the pull through wire was wrapped around the graft and the stent became crossed inside the aorta and partially deployed.The physician was unable to straighten the wire to see the graft in the bifurcation of the iliacs.The physician elected to abort the stent graft placement and converted to an open procedure to explant the graft.The stent graft was explanted successfully, and the physician completed a repair with a non-endologix aorto-bi-femoral dacron graft.Post procedure, the patient was transferred to intensive care unit (icu), intubated, and later expired.The device will not be returned as it was disposed of by the facility.During the investigation, it was confirmed that the initial procedure was off-label due to absence of an aortic aneurysm, concomitant use with products outside the ifu, and under-sizing of the iliac limbs and aortic neck anatomy.Note: endologix received medwatch reports # mw5096848 and mw5096936 for this reported event / patient.

Manufacturer Narrative

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 was disposed by the explanting hospital.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 event of difficulty to deploy, conversion to open repair, and device explant are confirmed per the operative notes.This is consistent with the reported adverse event / incident.Device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review; in addition, no definitive cause of death was noted in the medical records.During the investigation, endologix found reasonable evidence to suggest the device was used off-label due to the following factors: absence of an aortic aneurysm, concomitant use with products outside the ifu, the right common iliac artery was 7.8mm (should be 10-23mm per ifu), the left common iliac artery was 7.0mm (should be 10-23mm per ifu), and distal aortic neck was 11.3 (should be 18-32mm per ifu).The procedure-related harms for this event were abnormal blood loss and cardiac arrest four times.The final patient status was reported as expired on (b)(6) 2020 at 0443.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: d11: concomitant product.G4: awareness date.H6: evaluation result codes; remove 3233.H6: evaluation conclusion codes; remove 11.

• Brand Name: AFX2
• Type of Device: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10627797
• MDR Text Key: 209815667
• Report Number: 2031527-2020-00281
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009015075
• UDI-Public: (01)00818009015075(17)230211
• 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: 09/15/2020

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: 02/11/2023
• Device Model Number: BEA22-40/I13-40
• Device Lot Number: 2331372009
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX INTRODUCER SYSTEM II, SN: (B)(6).
• Patient Outcome(s): Death
• Patient Age: 56 YR