MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-80/I16-40
Medical Device Problem Codes	Material Puncture/Hole (1504); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	02/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.Device iteration is afx with duraply.Devices remain implanted in patient.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately five and a half (5.5) years post initial procedure, the patient presented at routine follow-up with a type iiib endoleak as detected by ct (computed tomography) scan.The physician will continue to monitor the patient who is reportedly in good condition.As of date, 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 of the distal bifurcated stent graft event and sac growth of 23.5mm were identified.The type 3b endoleak was likely user related due to the non-endologix iliac stents that were present in the bilateral iliac arteries (an off-label use, concomitant product use).The procedure related harms identified were a prolonged hospitalization.The final patient status was discharged on the seventh hospitalization day home stable following an endovascular repair procedure with a non endologix stent.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¿.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately five and a half (5.5) years post initial procedure, the patient presented at routine follow-up with a type iiib endoleak as detected by ct (computed tomography) scan.The physician will continue to monitor the patient who is reportedly in good condition.As of date, there have been no additional patient sequelae reported.Additional information: during the clinical investigation, sac growth of 23.5mm was identified.Also the off-label use of non-endologix iliac stents were present in the bilateral iliac arteries.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9775141
• Report Number: 2031527-2020-00070
• Device Sequence Number: 16690600
• Product Code: MIH
• UDI-Device Identifier: 00818009010018
• UDI-Public: (01)00818009010018(17)170703
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/03/2020

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: 07/03/2017
• Device Model Number: BA25-80/I16-40
• Device Lot Number: 1251741-026
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 07/29/2020
• 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: AFX VELA SUPRARENAL 1246584-003; AFX VELA SUPRARENAL 1246584-003
• Outcome Attributed to Adverse Event: Other
• Patient Age: 89 YR