MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; BIFURCATED STENT GRAFT

Model Number	BA25-90/I16-30
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.Device iteration is afx with duraply.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately four (4) years post initial procedure, the patient presented with a type iiib endoleak per ct (computed topography).The physician elected to treat the patient by relining with medtronic (non-endologix) devices on an unknown date.The final ultrasound confirmed the endoleak was resolved, and the patient is reportedly in stable condition.As of date, there have been no additional patient sequelae reported.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately four (4) years post initial procedure, the patient presented with a type iiib endoleak per ct (computed topography).The physician elected to treat the patient by relining with medtronic (non-endologix) devices on an unknown date.The final ultrasound confirmed the endoleak was resolved, and the patient is reportedly in stable condition.As of date, there have been no additional patient sequelae reported.Additional information received per clinical assessment confirming that the patient was relined with a non-endologix stent on (b)(6) 2019 per ct study.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was unsubstantial evidence to support the reported event of a type iiib endoleak, but the reline with a non-endologix stent was confirmed per 44-month ct scan.The clinical assessment determined that there was also evidence to reasonably suggest type ii endoleaks of the lumbar arteries with aneurysm sac growth of 31.5mm occurred that were not included in the event as reported; these were discovered during review of the 2-month post implant ct scan.Procedure-related harms and device, user, procedure, or anatomy relatedness of this event could not be determined.The final patient status was reported to be in stable condition.The manufacturing lot review confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.Correction: a2 age, g1-2 contact office, g4, h6; h6 device code ¿ remove 2978.H6 result code ¿ remove 3233.H6 conclusion code ¿ remove 11 and 22.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 8928735
• Report Number: 2031527-2019-00387
• Device Sequence Number: 290188
• Product Code: MIH
• UDI-Device Identifier: 00818009010230
• UDI-Public: (01)00818009010230(17)180212
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2019

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: 02/12/2018
• Device Model Number: BA25-90/I16-30
• Device Lot Number: 1252264-020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 08/24/2019
• Supplement Report FDA Received Date: 03/16/2020
• 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-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL: 1309265-009
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR