MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA25-70/I16-30

Device Problems Complete Blockage (1094); Insufficient Information (3190)

Patient Problems Ischemia (1942); Necrosis (1971)

Event Date 04/07/2021

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 afx2.

Event Description

The patient was initially implanted with an afx2 bifurcated stent graft and gore (non-endologix) excluder legs to treat an abdominal aortic aneurysm (aaa); this initial implant is outside the indications of use.Approximately (20) twenty days post initial procedure, it was reported that at an unknown date the patient was found to have necrosis in the large intestine.The large intestine was removed.It's possible that the necrosis occurred because the blood flow to the area was blocked due to the embolization of both internal iliac arteries and the occlusion of the inferior mesenteric and lumbar arteries with the afx2 bifurcated stent graft.The patient was discharged after the surgery to treat the necrosis.

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.Ian 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 mesenteric occlusion and ischemia is unconfirmed.This is not consistent with the reported adverse event/incident.The clinical evaluation also shows the procedure related harm identified was an additional surgical procedure (colostomy).Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the lack of records and imaging available for review.The final patient status was reported to be discharged after the additional surgical procedure.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: g1,2: contact office- name has been updated.H6 evaluation result codes; remove 3233.H6 evaluation conclusion codes; remove 11.

• Brand Name: AFX2
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11780268
• MDR Text Key: 252330850
• Report Number: 2031527-2021-00188
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014870
• UDI-Public: (01)00818009014870(17)2342799011
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2023
• Device Model Number: BEA25-70/I16-30
• Device Lot Number: 2342799-001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR