MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ULTRA DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9630TF29

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

The complaint device (ultra delivery system - model 9630tf29) is not sold or marketed in the us; however it is deemed similar to the (commander delivery system - model 9600lds29).The pma/510k field will be blank.The lot number is 60398208.Investigation is ongoing.

Event Description

As reported by our affiliates in (b)(4), when the shipment was opened it was noted that the styrofoam containers holding the valves were not taped shut and product had partially spilled out of the containers.The inner boxes containing the valves are intact except for one.There was a piece of tape over the serial number and expiration date.When removing that piece of tape the last digit of the serial number was mostly removed and the expiration date completely removed.

Manufacturer Narrative

Additional information provided indicates that the sterility of the device was not compromised.The device was sent sterile, and became damaged.The new information indicates that the outer cardboard box was opened and the styrofoam inner box and valve box were free in the kit box.The valve box was intact, although the tape had ripped off one of them.This event is no longer reportable.

• Brand Name: EDWARDS ULTRA DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 5745072
• MDR Text Key: 48057125
• Report Number: 2015691-2016-02025
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2017
• Device Model Number: 9630TF29
• Device Lot Number: 60398208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2016
• 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 Outcome(s): Other