MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-70/I16-30
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Separation Problem (4043)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation.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 an afx bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately five (5) years post initial procedure, a computed tomography angiogram revealed the patient had a 3a endoleak with component separation.A re-intervention was attempted but was unsuccessful.A few days later, the physician then elected to perform an open repair and explant the device.Reportedly the explant went well and the patient is stable.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned.The type iiia endoleak with complete component separation of the aortic components event was confirmed.Device, user, procedure or anatomy relatedness of this complaint could not be determined.The unsuccessful endovascular repair procedure is confirmed (unable to pass guidewire).There were no procedure related harms identified.The final patient status was discharged on post operative day nine stable to a skilled nursing facility due to overall debilitated state.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.¿device iteration is afx with duraply.".

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10018184
• Report Number: 2031527-2020-00146
• Device Sequence Number: 3303691
• Product Code: MIH
• UDI-Device Identifier: 00818009010100
• UDI-Public: (01)00818009010100(17)170908
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/06/2020

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: 09/08/2017
• Device Model Number: BA25-70/I16-30
• Device Lot Number: 1275835026
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 08/06/2020
• 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 1252025011; VELA SUPRARENAL, LOT 1252025011
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR