MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; BIFURCATED STENT GRAFT

Model Number	BA28-90/I20-30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/18/2019
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 implanted with a bifurcated stent graft and two (2) infrarenal stent graft extensions to treat an abdominal aortic aneurysm (aaa).Approximately 3.5 years post initial procedure, a type 2 endoleak (non - device related failure) of inferior mesenteric artery (ima) was reported and the physician elected to coil the ima.Now, approximately four (4) years post initial procedure, a type 1b endoleak on the right side was identified during a routine follow up.An intervention was completed.The physician elected to reline the original implanted devices with an afx2 bifurcated stent graft, a vela suprarenal stent graft extension and two (2) ovation ix extender to resolve this reported event.The patient was reported to be discharged post intervention with no issues.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported type ib endoleak from bilateral common iliac arteries, secondary endovascular procedure was confirmed.Device, user, procedure or anatomy relatedness of the for the distal loss of seal could not be determined due to the lack of a pre evas ct study.The final patient status was reported being stable.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.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: g1,2: contact office- name has been updated h6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 8805500
• Report Number: 2031527-2019-00322
• Device Sequence Number: 16817779
• Product Code: MIH
• UDI-Device Identifier: 00818009012630
• UDI-Public: (01)00818009012630(17)170708
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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: 07/08/2017
• Device Model Number: BA28-90/I20-30
• Device Lot Number: 1251901-007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COILS (NON ENDOLOGIX); VELA INFRARENAL, LOT 1247645-014; VELA INFRARENAL, LOT 1252143-010
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR