MAUDE Adverse Event Report: EDWARDS LIFESCIENCES VALVE KIT INTUITY; HEART VALVE, NON-ALLOGRAFT TISSUE

Model Number 8300KITB27A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 10/10/2017

Event Type  malfunction  

Event Description

During the avr procedure, the surgical techs prepared the valve and delivery for the implant and handed to the surgeon.The surgeon placed the suture and parachuted the valve and delivery system on to the annulus.The surgeon noticed the valve was loose on the connection to the delivery system and was not happy how the connection was.He did not like the way the valve was loose, could not fix the valve and decided to not use the valve.The valve was not tied down nor deployed.It was simply removed and a new kit was opened and successfully implanted with the same size.The patient was discharged without further incident.

• Brand Name: VALVE KIT INTUITY
• Type of Device: HEART VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES
• MDR Report Key: 6975788
• MDR Text Key: 90308175
• Report Number: MW5072932
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2019
• Device Model Number: 8300KITB27A
• Device Catalogue Number: S60885795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 137