MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-100/I16-40
Medical Device Problem Codes	Material Puncture/Hole (1504); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/21/2020
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 and a suprarenal stent graft extension to treat an abdominal aortic aneurysm.Approximately 5 years post initial procedure, a follow-up computed tomography angiogram revealed a type iiia and a iiib endoleak.Patient is doing well and is pending re-intervention.
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 iiia endoleak with complete component separation event is confirmed.The type iiib endoleak of the distal bifurcated stent graft event is confirmed and is most likely user related and due to the off-label use of concomitant products (non endologix left common iliac stent present).Due to the lack of comparative and index procedure imaging, the contributing factor for the type iiia endoleak could not be determined.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 not reported.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 remove code 3190.H6: method remove code 3233.H6: conclusion remove code 11.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm.Approximately 5 years post initial procedure, a follow-up computed tomography angiogram revealed a type iiia and a iiib endoleak.Patient is doing well and is pending re-intervention.Additional information: a re- intervention was completed on (b)(6) 2020.The physician elected to implanted an afx bifurcated stent graft and a non-endologix device (cook thoracic cuff) to resolve this event.The final patient status was reported as fine.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9730901
• Report Number: 2031527-2020-00049
• Device Sequence Number: 14053654
• Product Code: MIH
• UDI-Device Identifier: 00818009010032
• UDI-Public: (01)00818009010032(17)170620
• 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: 2014
• 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): 01/21/2020

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: 06/20/2017
• Device Model Number: BA25-100/I16-40
• Device Lot Number: 1252294031
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 07/21/2020
• 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: VELA SUPRARENAL, LOT#1260661032.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR