MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-70/I16-30
Medical Device Problem Codes	Material Puncture/Hole (1504); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for a ruptured abdominal aortic aneurysm (aaa) with the implant of an afx2 bifurcated stent graft and an afx vela suprarenal.This procedure is outside the indications of use (off-label) due to emergent use of the afx system per device ifu.Approximately (3) three year post initial procedure a computerized tomography (ct) scan visualized a type 3a endoleak.Re-intervention was completed with the implant of an afx vela suprarenal which resolved the type 3a endoleak.The patient's current condition is unknown.
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.
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 the reported type 3a endoleak of the aortic components is refuted, rather a type 3b endoleak (of the bifurcated stent graft) is confirmed.This is not consistent with the reported adverse event/incident.No procedure-related harms were identified.A possible contributing factor to the type 3b endoleak was the thickened calcium at the bifurcation, however this could not be conclusively determined.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 not reported.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 d6a case date g2 report source g3 awareness date h6 medical device problem codes; remove 3191 h6 investigation conclusion codes; remove 11.
Event or Problem Description
Clarification: the patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the afx2 bifurcated stent graft and an afx vela infrarenal.Approximately three and a half (3.5) years post initial procedure, a computerized tomography (ct) scan visualized a type 3a endoleak.Re-intervention was completed with the implant of an additional afx vela infrarenal, which resolved the type 3a endoleak.The patient's current condition is unknown.Additional information: clinical assessment refuted the reported type 3a endoleak, and rather confirmed the presence of a type 3b endoleak of the bifurcated stent graft.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; ,; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; ,; irvine, CA 92618 ; 8009832284
• MDR Report Key: 14471400
• Report Number: 2031527-2022-00107
• Device Sequence Number: 4722794
• Product Code: MIH
• UDI-Device Identifier: 00818009015143
• UDI-Public: (01)00818009015143(17)190116
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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: 01/16/2019
• Device Model Number: BEA22-70/I16-30
• Device Lot Number: 1776543-009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: AFX VELA INFRARENAL 1969698002.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male