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

Model Number	BA25-80/I16-40
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
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 had a contrast-ct (computed topography) performed and a type iiib endoleak was found.The physician plans to re-intervene but surgery has not been scheduled.No further additional information or patient sequalae has been reported at this time.
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 had a contrast-ct (computed topography) performed and a type iiib endoleak was found.The physician plans to re-intervene but surgery has not been scheduled.No further additional information or patient sequalae has been reported at this time.Subsequent to the initial report, additional information was provided reporting that the type iiib endoleak was successfully sealed with relining the originally implanted devices with an afx2 bifurcated stent system and an afx vela infrarenal.No additional information was provided.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The type iiib endoleak complaint is unconfirmed due to a lack of relevant medical imaging.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.The final patient status was not reported.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx with duraply.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 8845696
• Report Number: 2031527-2019-00331
• Device Sequence Number: 2716488
• Product Code: MIH
• UDI-Device Identifier: 00818009010018
• UDI-Public: (01)00818009010018(17)170623
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/10/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2017
• Device Model Number: BA25-80/I16-40
• Device Lot Number: 1251742-041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 04/16/2020
• 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: 1329542-016; AFX VELA SUPRARENAL: 1329542-016
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR