MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number	I20-13/C88F SA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984); Pain (1994)
Date of Event	05/13/2020
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 a bifurcated stent graft, a suprarenal stent graft extension and (2) limb stent graft extensions to treat an abdominal aortic aneurysm.Approximately 5 years post initial procedure, the patient presented symptomatic with right leg rest pain and occlusion of the left iliac limb was identified.The physician elected to perform a fem-fem bypass and patient is doing well.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft, a suprarenal stent graft extension and (2) limb stent graft extensions to treat an abdominal aortic aneurysm.Approximately 5 years post initial procedure, the patient presented symptomatic with right leg rest pain and occlusion of the left iliac limb was identified.The physician elected to perform a fem-fem bypass and patient is doing well.Additional information: clinical assessment identified occlusion of the right limb, not the left limb as initially reported, and a type 3a endoleak of the right common iliac artery.
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, clinical was able to find substantial evidence to support the following event of the occlusion of the right common iliac artery.Procedure related harms, device, user, procedure or anatomy relatedness of this event could not be determined with the medical records and imaging available to review.Clinical assessment also identified a type 3a endoleak of the right common iliac artery during review of the sixty-two (62) month post implant computed tomography (ct) scan dated (b)(6)2020, however was unable to determine causation with the imaging available to review.The final patient status was reported to be doing well following a fem-fem bypass.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: b1: adverse event/product problem has been updated.B5: describe event or problem has been updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10139510
• Report Number: 2031527-2020-00168
• Device Sequence Number: 11298321
• Product Code: MIH
• UDI-Device Identifier: 00818009011459
• UDI-Public: (01)00818009011459(17)171110
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/14/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/10/2017
• Device Model Number: I20-13/C88F SA
• Device Lot Number: 1252598017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 08/20/2020
• 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-0009-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIFURCATED STENT GRAFT; LIMB STENT GRAFT; VELA SUPRARENAL; BIFURCATED STENT GRAFT; LIMB STENT GRAFT; VELA SUPRARENAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR