MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-80/I16-55
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); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this 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, a suprarenal stent graft extension and an infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, the patient presented at routine follow-up with a migrated (by 20mm) proximal stent graft extension and a type 3b endoleak of the bifurcated stent graft.A re-intervention was performed.The physician elected to reline the original implanted devices with ovation ix abdominal stent graft system (one main body and 4 iliac limbs) to resolve this event.The patient was reported as doing 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 migration of 13.1mm of the suprarenal stent and the type iiib endoleak of the distal bifurcated stent graft were confirmed, is confirmed.The type iiib endoleak was present at the 1 day post index procedure, suggesting an intraoperative failure/user error.The concomitant use of a non endologix stent in the left common iliac artery placed sometime between the event and the index procedure, could have contributed to this event (off label use).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: result remove code 3233.H6: conclusion remove code 11.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9714952
• Report Number: 2031527-2020-00045
• Device Sequence Number: 11494786
• Product Code: MIH
• UDI-Device Identifier: 00818009010070
• UDI-Public: (01)00818009010070(17)180820
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 01/17/2020

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: 08/20/2018
• Device Model Number: BA25-80/I16-55
• Device Lot Number: 1252289-004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 07/22/2020
• 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 INFRARENAL, LOT 1252150013; VELA SUPRARENAL, LOT 1449834004
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR