MAUDE Adverse Event Report: ST JUDE MEDICAL HEART VALVE

Model Number 21AGFN-756

Device Problem Detachment Of Device Component (1104)

Patient Problem Death (1802)

Event Date 02/09/2015

Event Type  Death  

Event Description

During implantation of the heart valve, the device needed to be rotated to allow the leaflets to move freely.During this rotation, one of the leaflets detached from the body of the valve.As such, the valve had to be removed and replaced for a second time.The pt subsequently underwent a bypass procedure as part of the same surgical encounter.The pt expired on post-op day 2.

• Brand Name: HEART VALVE
• Type of Device: HEART VALVE
• Manufacturer (Section D): ST JUDE MEDICAL
• MDR Report Key: 4569661
• MDR Text Key: 17581438
• Report Number: MW5041070
• Device Sequence Number: 1
• Product Code: LWR
• 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: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2015
• Device Model Number: 21AGFN-756
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 46 YR
• Patient Weight: 68