MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-110/I20-30
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/01/2019
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 treated with afx bifurcated stent graft and (2) suprarenal extensions to treat an abdominal aortic aneurysm (aaa).Approximately 3 years post initial implant, the physician treated the patient for aneurysm growth of the rci (right common iliac), this was a non device related event.An ovation ix extender stent graft to resolve this event.This procedure is outside the indications of use (off -label).Now, approximately 4 year post initial procedure, a type 3b endoleak with sac expansion was identified during a routine follow up.The physician elected to treat the patient by relining with the ovation ix abdominal stent graft system.As of the date of this report, there have been no additional patient sequelae reported.
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 iiib endoleak with sac growth event was refuted, rather there was a type 1b endoleak from the left common iliac artery with sac growth.The secondary endovascular procedure is confirmed.This events are most likely anatomy related due to the remodeling of the iliac anatomy.The procedure related harms for this compliant could not be determined.The final patient status was reported being stable.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: h6: device code: remove 3190 h6: result code: remove code 3233 h6: conclusion code: remove code 11 h7: remove recall h9: remove recall number.
Event or Problem Description
The patient was initially treated with afx bifurcated stent graft and (2) suprarenal extensions to treat an abdominal aortic aneurysm (aaa).Approximately 3 years post initial implant, the physician treated the patient for aneurysm growth of the rci (right common iliac), this was a non device related event.An ovation ix extender stent graft to resolve this event.This procedure is outside the indications of use (off -label).Now, approximately 4 year post initial procedure, a type 3b endoleak with sac expansion was identified during a routine follow up.The physician elected to treat the patient by relining with the ovation ix abdominal stent graft system.As of the date of this report, there have been no additional patient sequelae reported.Additional information: the reported type 3b endoleak with sac growth was refuted, rather it is was a type 1b from the left common iliac artery with sac growth.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9293778
• Report Number: 2031527-2019-00499
• Device Sequence Number: 19299015
• Product Code: MIH
• UDI-Device Identifier: 00818009014214
• UDI-Public: (01)00818009014214(17)180921
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/09/2019

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: 09/21/2018
• Device Model Number: BA28-110/I20-30
• Device Lot Number: 1352185004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 06/19/2020
• 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: OVATION IX EXTENDER, LOT#FS022619-25; VELA SUPRARENAL, LOT#1252482031; VELA SUPRARENAL, LOT#1252491004
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR