MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number I20-13/C70F SA

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354); Material Rupture (1546)

Patient Problems Failure of Implant (1924); Pain (1994); Rupture (2208)

Event Date 12/02/2017

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

On (b)(6) 2014, the patient was initially implanted with a bifurcated stent, a suprarenal extension and a limb extension.On (b)(4) 2017 endologix was made aware a 1b endoleak.It was reported that the patient went to the hospital with abdominal pain.A type 1b endoleak from right common iliac with possible rupture was discovered.The physician elected to implant another limb stent extension to seal the leak.No evidence of endoleak was present on final angiogram.The patient was reported as stable.

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 only able to find substantial evidence to support the following reported event of a secondary endovascular procedure.Clinical was unable to find substantial evidence to support the following reported events of type ib endoleak of the right common iliac, a rupture and that the patient condition in stable due to the lack of medical information.Several attempts were made to retrieve the medical records and images.These requests were denied.The most likely cause of the distal loss of seal and possible rupture could not be determined due to the lack of medical information surrounding the initial implant procedure, rupture event and the reported secondary intervention.Reportedly, the patient was in stable condition post the secondary repair procedure.To date there has been no reports of further negative patient sequelae.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX
• Type of Device: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7149381
• MDR Text Key: 95870701
• Report Number: 2031527-2017-00698
• 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: 12/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: I20-13/C70F SA
• Device Lot Number: 1230491-011
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIFURCATED STENT GRAFT, LOT # 1252257048; VELA SUPRARENAL, LOT # 1264514028; BIFURCATED STENT GRAFT, LOT # 1252257048; VELA SUPRARENAL, LOT # 1264514028
• Patient Outcome(s): Congenital Anomaly; Required Intervention
• Patient Age: 83 YR