MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-100/I20-40
Medical Device Problem Codes	Fracture (1260); Material Puncture/Hole (1504); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Additional 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.Device remains implanted in patient.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and (2) two vela suprarenal's to treat an abdominal aortic aneurysm (aaa).During the procedure, a type 1a endoleak was confirmed on the angiography, so another vela suprarenal was implanted.Approximately (2) years post initial implant procedure the patient was identified with type 1b endoleak.The patient status is unknown at this time.
Additional 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 type 3b endoleak, type 2 endoleak, sac growth, secondary endovascular procedure and stent fracture are confirmed.This is moderately consistent with the reported adverse event/incident.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review; however, the most likely causation for the type 3b endoleak was due to the stent fracture.The final patient status remains unknown.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: device code: remove code 3190; h6: result code: remove code 3233; h6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and (2) two vela suprarenal's to treat an abdominal aortic aneurysm (aaa).During the procedure, a type 1a endoleak was confirmed on the angiography, so another vela suprarenal was implanted.Approximately (2) years post initial implant procedure the patient was identified with type 1b endoleak.The patient status is unknown at this time.Additional information: an angiogram was done and revealed a type 3b endoleak and the aneurysm diameter was confirmed to have increased to 8 cm.The physician elected to implant another afx2 bifurcated stent graft to resolve this event.A type 2 endoleak remained and the procedure was completed without further treatment.Additionally during the internal investigation stent fracture was identified.Note: type 2 endoleaks are anatomy related events and are not caused or contributed by the device.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11868164
• Report Number: 2031527-2021-00214
• Device Sequence Number: 2990060
• Product Code: MIH
• UDI-Device Identifier: 00818009014672
• UDI-Public: (01)00818009014672(17)190206
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2020
• Device Model Number: BEA25-100/I20-40
• Device Lot Number: 1783499-001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 05/22/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VELA SUPRARENAL 2207151-006.; VELA SUPRARENAL 2241390-002.; VELA SUPRARENAL 2241390-008.
• Outcome Attributed to Adverse Event: Other; Required Intervention