MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-80/I20-40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted device was not returned by the hospital; therefore, a device evaluation will not be performed.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 afx2.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft, an afx vela suprarenal, and an afx limb stent graft to treat an abdominal aortic aneurysm (aaa).Approximately two (2) years post initial procedure, sac expansion of an unknown diameter was identified during a routine computerized tomography scan.The patient was reported to be asymptomatic.Explant and of the device and open repair surgery placing a tube graft was performed.The procedure was successful, and the patient did well.
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 sac growth of 10mm and the surgical conversion events are 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 discharged on the fifth postoperative day home stable following a surgical conversion.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 afx2.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10096292
• Report Number: 2031527-2020-00158
• Device Sequence Number: 19613619
• Product Code: MIH
• UDI-Device Identifier: 00818009014955
• UDI-Public: (01)00818009014955(17)180522
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: 05/22/2018
• Device Model Number: BEA22-80/I20-40
• Device Lot Number: 1689651002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 05/28/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX LIMB STENT GRAFT (LN 1727526010); AFX VELA SUPRARENAL (LN 1754822003)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR