MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; SUPRARENAL AORO UNI-ILIAC

Model Number A34-34/C80-O20 V

Device Problems Device Markings/Labelling Problem (2911); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been received and is pending evaluation.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

Two vela suprarenal aortic extension devices were labeled with the ame lot/serial number.Both products were distributed, one product was used in a procedure and the second device was not used in a procedure.The device not used in a procedure was returned to the company.There is no patient harm associated with this labeling issue.

Manufacturer Narrative

At the completion of the complaint investigation, based on returned product evaluation, the reported event was confirmed.There was no patient injury associated with this event.Further investigation of this complaint event was completed and the root cause was identified as a manufacturing process issue.Since automation is currently not used to generate or verify product labels including the lot/serial numbers, process improvements were completed and finished goods' procedures were updated and implemented to prevent this event from reoccurrence.Correction: device codes, method codes, results codes, and conclusion codes updated.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORO UNI-ILIAC
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6323600
• MDR Text Key: 67231782
• Report Number: 2031527-2017-00061
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009013606
• UDI-Public: (01)00818009013606(17)190126
• Combination Product (y/n): N
• PMA/PMN Number: PO40002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2019
• Device Model Number: A34-34/C80-O20 V
• Device Lot Number: 1457893-029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2016
• 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