MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-80/I20-40
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will be returned for evaluation.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx with duraply.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft and an afx vela suprarenal proximal extension.Approximately three (3) years post initial procedure, the patient presented with a type ib endoleak.The physician elected to treat the patient by implanting a non-endologix prosthetic extension in the left leg sometime in year 2020.This type ib endoleak will be reported under a separate medical device report (mdr).Approximately two (2) years post secondary procedure, the patient presented with an endoleak (at indeterminate origin).The physician elected to convert patient to open repair and explant the afx devices.The final patient status was not reported.The explanted devices are available for return/evaluation.
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.A clinical evaluation of the adverse event/incident could not be completed.No medical records or medical imaging relevant to the adverse event/incident was received by endologix.Due to the absence of relevant medical records and reported medical imaging; device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.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 afx with duraply.Corrections: h6 investigation type codes; remove 4118.H6 investigation finding codes; remove 3233.H6 investigation conclusion codes; remove 11.

• Brand Name: AFX
• 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: 14026766
• Report Number: 2031527-2022-00075
• Device Sequence Number: 20367707
• Product Code: MIH
• UDI-Device Identifier: 00818009012265
• UDI-Public: (01)00818009012265(17)190929
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2022

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: 09/29/2019
• Device Model Number: BA28-80/I20-40
• Device Lot Number: 1595273-009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2016
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL, SN (B)(4); NON-ENDOLOGIX PROSTHETIC EXTENSION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown