MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED STENT GRAFT

Model Number BEA28-100/I16-40

Device Problems Break (1069); Detachment Of Device Component (1104); Torn Material (3024)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2017

Event Type  malfunction  

Manufacturer Narrative

To date the incident device has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Devices have not been returned.

Event Description

An initial implant procedure was performed on (b)(6) 2017 with a afx2 bifurcated stent.After the placement of the bifurcated stent the physician removed the yellow deployment cord and during the removal of the cord the physician did not see the red ptfe stent covering come out with the cord.The physician continued the deployment procedure with no issue.At the completion of the procedure the physician observed the red ptfe covering inside the afx sheath.It was believed the covering became disconnected from the proximal portion of the delivery system during deployment.There was no reported injury to the patient.The patient is reported to be in stable condition.No additional adverse events were reported for this patient.

Manufacturer Narrative

Clinical evaluation: based on a lack of medical information, there was no evidence to support the following reported events: torn red ptfe main body cover.Clinical was unable to find evidence to reasonably suggest contributing factor(s) to the reported event due to limited available patient information.Root cause: based on the information available the root cause of the reported event could not be determined.Corrected data: (b)(4).

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: michelle caulfield ; 2 musick; irvine, CA 92618 ; 9495984606
• MDR Report Key: 6532158
• MDR Text Key: 74102797
• Report Number: 2031527-2017-00197
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014450
• UDI-Public: (01)00818009014450(17)170809
• 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,Followup
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2017
• Device Model Number: BEA28-100/I16-40
• Device Lot Number: 1562393-015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2016
• 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
• Patient Age: 77 YR