MAUDE Adverse Event Report: ENDOLOGIX AFX; SUPRARENAL AORTIC EXTENSION

Model Number A34-34/C100-O20

Device Problems Fracture (1260); Stretched (1601)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2018

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 a bifurcated and suprarenal stent graft in 2013.On (b)(6) 2018, the patient received a ct scan which showed dilation and fracture of the suprarenal cuff.The sac is stable and there was no evidence of an endoleak.Patient is currently doing well and will undergo diagnostic angiography.The physician is considering a reline, but a date has not been scheduled.As of this report, no additional patient sequelae has been reported.

Event Description

Additional information: a secondary procedure was completed.The physician elected to reline the original implanted devices with another bifurcated stent graft, and a suprarenal stent graft extension to resolve this event.It was reported that the patient did well.

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, due to the lack of relevant medical imaging, clinical was unable to find substantial evidence to support the following events of dilation and fracture of the proximal extension.Several attempts were made to obtain medical records and/or images from the medical center where the intervention was completed but no response was received.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined.The final patient status was reported to be well 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.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7985243
• MDR Text Key: 124355684
• Report Number: 2031527-2018-00785
• Device Sequence Number: 1
• Product Code: MIH
• 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
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2016
• Device Model Number: A34-34/C100-O20
• Device Lot Number: 1047244-019
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/19/2018
• Supplement Dates Manufacturer Received: 03/28/2019
• Supplement Dates FDA Received: 03/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX-BIFURCATED-LOT: 1111679-005; AFX-BIFURCATED-LOT: 1111679-005
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR