MAUDE Adverse Event Report: ST. JUDE MEDICAL, PUERTO RICO, B.V. SJM MASTERS SERIES MECHANICAL HEART VALVE

Model Number 23AJ-501

Device Problems Gradient Increase (1270); Compatibility Problem (2960)

Patient Problem Aortic Insufficiency (1715)

Event Date 12/17/2013

Event Type  Injury  

Event Description

The info provided to sjm indicated a 23mm masters series valve was implanted on (b)(6) 2012.An echocardiogram revealed a gradient of 100mmhg and aortic insufficiency.The valve was explanted on (b)(6) 2013.It was reported that there was no pannus formation and the gradient was likely due to a pt/prosthesis mismatch.An aortic root enlargement was performed.A 27mm masters series valve (s/n # (b)(4) was implanted.The pt was discharged on (b)(6) 2013.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Manufacturer (Section D): ST. JUDE MEDICAL, PUERTO RICO, B.V.; caguas PR
• Manufacturer Contact: denise johnson, rn ; 177 east county road b; st. paul, MN 55117 ; 6517564470
• MDR Report Key: 3883566
• MDR Text Key: 16224460
• Report Number: 2648612-2014-00001
• 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: Other
• Type of Report: Initial
• Report Date: 01/03/2014

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: 05/26/2009
• Device Model Number: 23AJ-501
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2014
• Initial Date FDA Received: 01/24/2014
• Date Device Manufactured: 05/19/2004
• 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: 23 YR
• Patient Weight: 97