MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA25-90/I20-30

Device Problems Fracture (1260); Material Puncture/Hole (1504); Product Quality Problem (1506); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

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.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately 3.5 years post initial procedure, a type ia endoleak (of the proximal extension) and a possible type iiib endoleak at the crotch of the bifurcated device were detected.However, the exact date of event is unknown.The physician elected to treat the patient by successfully relining with non-endologix stents on (b)(6) 2019.The patient is reportedly doing well post re-intervention.There have been no additional patient sequelae reported.

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, clinical was able to find substantial evidence to support the following events of a type 1a endoleak of the proximal extensions and a 3b endoleak, stent fracture and stent cage dilation of the bifurcated stent graft.The type 1a endoleak is most likely user related due to the off-label neck anatomy.The neck was at 90° pre index procedure and should be equal or less than 60°.The cause of the type 3b endoleak, stent fracture and stent cage dilation could not be determined due to a lack of comparative imaging.The final patient status was reported to be good post successful secondary endovascular procedure.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, 22.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8613525
• MDR Text Key: 145166294
• Report Number: 2031527-2019-00244
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009012456
• UDI-Public: (01)00818009012456(17)171020
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2017
• Device Model Number: BA25-90/I20-30
• Device Lot Number: 1285399-004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0006-2019
• Patient Sequence Number: 1
• Treatment: AFX-VELA INFRARENAL:1252179-002; AFX-VELA INFRARENAL:1252537-026; AFX-VELA SUPRARENAL:1252477-024; AFX-VELA INFRARENAL: 1252179-002; AFX-VELA INFRARENAL: 1252537-026; AFX-VELA SUPRARENAL: 1252477-024
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR