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

Model Number	BEA28-70/I20-30
Medical Device Problem Codes	Device-Device Incompatibility (2919); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the 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 or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 bifurcated stent graft and a vela suprarenal stent graft extension.During the procedure a type 3a endoleak was identified.The physician elected to implant a non-endologix (palmaz) stent, but the endoleak remained unresolved.The physician is monitoring the patient and will perform a follow up computed tomography (ct) scan to see if the endoleak is still present.The patient is reportedly stable.
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.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the intraoperative type 3a endoleak event/incident as being confirmed.This is 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.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The contributing factors for an intraoperative type 3a endoleak are likely the off label infrarenal angle of 67.5° (ifu states less than 60°).The final patient status was reported as being under surveillance.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: g4 awareness date h6 device codes (as evaluated); remove 3190 h6 evaluation result codes; remove 3233 h6 evaluation conclusion codes; remove 11.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10779863
• Report Number: 2031527-2020-00311
• Device Sequence Number: 16406013
• Product Code: MIH
• UDI-Device Identifier: 00818009014566
• UDI-Public: (01)00818009014566(17)190920
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2021
• Device Model Number: BEA28-70/I20-30
• Device Lot Number: 1988914R003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 12/31/2020
• 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, LOT# 2350189002; VELA SUPRARENAL, LOT# 2350189002
• Outcome Attributed to Adverse Event: Other