MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA28-90/I20-30

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Aneurysm (1708)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient was initially implanted with an afx bifurcated, two limb, one vela suprarenal, and one ovation extender in (b)(6) 2018.Approximately one month later, the patient was noted with an aneurysm growth and without any leak seen.The physician elected to explant the graft and noted that there were no identifiable endoleak.As of this report, no additional patient sequalae has been reported.

• Brand Name: AFX2
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7658728
• MDR Text Key: 113026438
• Report Number: 2031527-2018-00577
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014559
• UDI-Public: (01)00818009014559(17)190122
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2018

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
• Device Operator: Physician
• Device Expiration Date: 01/22/2019
• Device Model Number: BEA28-90/I20-30
• Device Lot Number: 1779054004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AFX-LIMB-LOT, 1616918011; AFX-LIMB-LOT, 1624506005; AFX-VELA SUPRARENAL-LOT: 1747394010; OVATION-EXTENDER LOT: FS010818-25
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR