MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA25-100/I16-40

Device Problems Complete Blockage (1094); Collapse (1099); Improper or Incorrect Procedure or Method (2017); Separation Problem (4043)

Patient Problem Failure of Implant (1924)

Event Date 04/24/2021

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, a suprarenal stent graft extension and an ovation extender to treat an abdominal aortic aneurysm (aaa).This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx system per the ifu.Approximately four years post initial implant the patient presented to the emergency room with a cold leg.A 3a endoleak was observed, the separation of the bifurcated stent graft collapsed causing an occlusion.The physician elected to implant a vela suprarenal and a vela infrarenal to restore seal and flow.The patient is doing well post secondary procedure.

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 reported type iiia endoleak (aortic) with complete component separation, and occlusion and buckling of the bifurcated stent graft are confirmed.This is consistent with the reported adverse event/incident.The contributing factor for the aortic occlusion is likely the stent buckling at 90 degrees, post complete component separation.Procedure-related harms, device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.The final patient status was reported as being stable post secondary endovascular 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: 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: 11826211
• MDR Text Key: 250667527
• Report Number: 2031527-2021-00205
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014726
• UDI-Public: (01)00818009014726(17)180215
• 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: 04/24/2021

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: 02/15/2018
• Device Model Number: BEA25-100/I16-40
• Device Lot Number: 1655220011
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/24/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 06/03/2021
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0007-2019
• Patient Sequence Number: 1
• Treatment: AFX VELA SUPRARENAL - 1672099010; OVATION IX EXTENDER - FS042616-21; AFX VELA SUPRARENAL - (B)(4) ; OVATION IX EXTENDER - FS042616-21
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR