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

Model Number BEA28-90/I16-30

Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

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

Event Date 04/26/2017

Event Type  Injury  

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.To date the device packaging not returned.

Event Description

A device was returned to endologix as part of recall process and the devices returned were reworked and fix with new labeling.During the rework process the inside packaging label did not match the outside packaging label.The device was sent into the field and was implanted in the patient.There has been no known or reported impact to the patient.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

Clinical evaluation is not applicable; device issue was prior to use on patient.Device was not returned for further evaluation, therefore sample evaluation was not completed.The review of manufacturing lot confirmed all devices met specifications prior to release.The root cause of the reported event seems to be a manufacturing deficiency and labeling issue.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.(b)(4).

• Brand Name: AFX2
• Type of Device: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX, INC; 2 musick; irvine CA 92618
• Manufacturer Contact: michelle caulfield ; 2 musick; irvine, CA 92618 ; 6495984606
• MDR Report Key: 6596109
• MDR Text Key: 76143496
• Report Number: 2031527-2017-00269
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 0081800901459
• UDI-Public: (01)0081800901459(17)171102
• 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: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2017
• Device Model Number: BEA28-90/I16-30
• Device Lot Number: 1612047009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2017
• 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 Outcome(s): Other
• Patient Age: 83 YR