MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; TISSUE, HEART-VALVE

Model Number 8300AB23

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

Udi # (b)(4).Additional information has been requested from the healthcare provider.There has been no response at this time.There is currently insufficient information to determine the root cause of this event.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If new information becomes available, a supplemental report will be submitted.

Event Description

It was reported that a patient with a 23mm 8300ab aortic pericardial valve has been referred to a surgeon for a redo-avr procedure after an implant duration of two (2) years, nine (9) months due to unknown reason.No other details were provided.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9706992
• MDR Text Key: 190785872
• Report Number: 2015691-2020-10492
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2018
• Device Model Number: 8300AB23
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR