MAUDE Adverse Event Report: ENDOLOGIX AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number BEA28-120/I16-40

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

Patient Problem Failure of Implant (1924)

Event Date 09/24/2018

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 afx2 abdominal aortic aneurysm stent.Approximately two (2) years post initial procedure, a type iiib endoleak with no aneurysm enlargement was detected per routine follow-up ct.The physician will continue to monitor the patient who is reportedly in good condition.There have been no additional patient sequelae reported.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following observations: the type iiib endoleak of the bifurcated device complaint is refuted and rather, there was noted contrast billowing (within acceptable range), stent cage buckling, and no aneurysm (sac) growth.The stent cage buckling was observed at one-month post initial implant.Procedure related harms and device, user, procedure, or anatomy relatedness of this complaint could not be determined.The final patient status was reported in good condition.

Event Description

Additional information received per clinical assessment confirming that there was no type iiib endoleak present at the time of the reported event; rather, clinical identified billowing and stent cage dilation of the bifurcated device.

• Brand Name: AFX2
• Type of Device: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8274203
• MDR Text Key: 133983708
• Report Number: 2031527-2019-00056
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014443
• UDI-Public: (01)00818009014443(17)170427
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/31/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2017
• Device Model Number: BEA28-120/I16-40
• Device Lot Number: 1356499-007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2018
• Initial Date FDA Received: 01/24/2019
• Supplement Dates Manufacturer Received: 12/31/2018
• Supplement Dates FDA Received: 03/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0006-2019
• Patient Sequence Number: 1
• Treatment: AFX-VELA SUPRARENAL:1472866-019; AFX-VELA SUPRARENAL:1472866-019
• Patient Outcome(s): Other
• Patient Age: 78 YR