MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CS-LILLEHEI) SJM MASTERS SERIES COATED AORTIC VALVED GRAFT

Model Number 21CAVGJ-514

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 03/04/2014

Event Type  Injury  

Event Description

The information provided to sjm indicated a 21mm masters series coated aortic valved graft was implanted on (b)(6), 2005.The valved graft was explanted on (b)(6), 2014 due to aortic stenosis.A larger 23mm sjm regent valve was implanted.

• Brand Name: SJM MASTERS SERIES COATED AORTIC VALVED GRAFT
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CS-LILLEHEI); st. paul MN
• Manufacturer Contact: denise johnson, rn ; 177 east county rd. b; st. paul, MN 55117 ; 6517564470
• MDR Report Key: 3738525
• MDR Text Key: 4307065
• Report Number: 2126673-2014-00003
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2008
• Device Model Number: 21CAVGJ-514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2014
• Date Device Manufactured: 02/15/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR