MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-90/I16-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/07/2019
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.The physician elected to treat the patient by relining with a gore (non-endologix) excluder.The patient was reportedly in good condition.As of date, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
The manufacturing lot review confirmed all devices met specifications prior to release.The devices were not returned as they remain implanted, and therefore no sample evaluation was completed.A clinical assessment was completed based on the received medical records.The reported additional endovascular and procedure (reline with medtronic aui device and fem-fem bypass on 07 august 2019) was confirmed.The type iiib endoleak was unconfirmed due to the provided non-contrast ct scan (poor imaging).There was also evidence to reasonably suggest the presence of a type iiia (aortic) endoleak per 43-month post index discharge summary.The following observations were likely contributing factors to the event: extreme infrarenal angulation of 74 degrees (aortic remodeling suspected), and the off-label initial implant of afx with no prior sizing of products.No procedure-related harms were identified, and the final patient status was reported in good condition.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.Corrections to g4, h6: h6 result code; remove 3233 h6 conclusion code; remove 11.
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.The physician elected to treat the patient by relining with a gore (non-endologix) excluder.The patient was reportedly in good condition.As of date, there have been no additional patient sequelae reported.Additional information received per clinical evaluation confirming that the initial implant was an emergent use of the afx system due to a pre-existing rupture, which is cautionary product use.A type iiia endoleak was also confirmed present at the time of the reported event per ct (computed tomography) scan from (b)(6) 2019; date of event therefore updated.Additionally, the re-intervention was confirmed to have been performed on (b)(6) 2019 in which the physician implanted a medtronic (non-endologix) aui (aorto-uni-iliac) device with a right iliac extension (unknown manufacturer), and a right-to-left femoral-femoral lia (left iliac artery) coil, which is an off-label procedure due to adjunctive use of non-endologix products.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9751726
• Report Number: 2031527-2020-00060
• Device Sequence Number: 679243
• Product Code: MIH
• UDI-Device Identifier: 00818009010230
• UDI-Public: (01)00818009010230(17)170625
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 01/28/2020

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: 06/25/2017
• Device Model Number: BA25-90/I16-30
• Device Lot Number: 1252257-003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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 INFRARENAL 1252180-022; AFX VELA SUPRARENAL 1252067-022; AFX VELA SUPRARENAL 1317911-023
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR