MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA25-100/I16-40

Device Problems Material Puncture/Hole (1504); Stretched (1601); Material Integrity Problem (2978)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately one (1) year post initial procedure, a type 3b endoleak was discovered during a routine follow up.The exact date of event is unknown.A secondary procedure was completed.The physician elected to reline the original implanted devices with non- endologix stent to treat the reported event.No further information was provided.

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: the reported type 3b endoleak was refuted rather there was distal fabric billowing of the bifurcated stent graft and a type 2 endoleak from the internal mesenteric artery.The distal fabric billowing is not a device failure.The material is designed to stretch.The type 2 endoleak is anatomy related, a non-device related failure.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
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8558663
• MDR Text Key: 143372296
• Report Number: 2031527-2019-00214
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014726
• UDI-Public: (01)00818009014726(17)180612
• 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: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2018
• Device Model Number: BEA25-100/I16-40
• Device Lot Number: 1702323-014
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Removal/Correction Number: DEVICE REMAINS IMPLANTED
• Patient Sequence Number: 1
• Treatment: VELA SUPRARENAL, LOT 1725055-010
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR