MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-110/I20-30
Medical Device Problem Codes	Material Puncture/Hole (1504); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Thrombus (2101)
Date of Event	04/14/2020
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 afx with duraply.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft, two (2) vela suprarenal stent graft extensions and a limb stent graft to treat an abdominal aortic aneurysm (aaa).Approximately 4.5 years later, a computed tomography angiogram confirmed a 1b endoleak (possible 3b) with thrombus burden within the endograft.The physician performed a re-intervention and elected to re-line the original implanted devices with an endurant (gore) device (non-endologix).Reportedly, the endoleak was resolved and patient tolerated the procedure well.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft, two (2) vela suprarenal stent graft extensions and a limb stent graft to treat an abdominal aortic aneurysm (aaa).Approximately 4.5 years later, a computed tomography angiogram confirmed a 1b endoleak (possible 3b) with thrombus burden within the endograft.The physician performed a re-intervention and elected to re-line the original implanted devices with an endurant (gore) device (non-endologix).Reportedly, the endoleak was resolved and patient tolerated the procedure well.Additional information: during clinical assessment, it was confirmed that the type ib endoleak of the right iliac artery and the type iiib endoleak of the distal bifurcated stent graft had occurred.
Additional Manufacturer Narrative
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.At the completion of the clinical assessment, the type ib endoleak of the right iliac artery is confirmed.The type iiib endoleak of the distal bifurcated stent graft event is confirmed.Procedure related harms, device, user, procedure or anatomy relatedness of this event could not be determined with the medical record/ images available for review.The final patient status was reported to be discharged on the first postoperative day home without complications.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; 2 musick; irvine CA 92618
• MDR Report Key: 10027168
• Report Number: 2031527-2020-00149
• Device Sequence Number: 2502073
• Product Code: MIH
• UDI-Device Identifier: 00818009014214
• UDI-Public: (01)00818009014214(17)171022
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: 10/22/2017
• Device Model Number: BA28-110/I20-30
• Device Lot Number: 1283285011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 08/10/2020
• 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: LIMB STENT GRAFT, LOT 1252606057; VELA SUPRARENAL, LOT 1252419009; VELA SUPRARENAL, LOT 1252419010
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR