MAUDE Adverse Event Report: ST. JUDE MEDICAL, PUERTO RICO, B.V. SJM MASTERS SERIES VALVE EXPANDED CUFF W/SILZONE; ROTATABLE HEART VALVE

Model Number 29AECS-602

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 09/20/2013

Event Type  Injury  

Event Description

The information provided to sjm indicated (b)(6) year old male patient underwent a valve replacement procedure with a 29mm masters series valve due to a paravalvular leak.The valve was explanted.

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED CUFF W/SILZONE
• Type of Device: ROTATABLE HEART VALVE
• Manufacturer (Section D): ST. JUDE MEDICAL, PUERTO RICO, B.V.; caguas PR
• Manufacturer Contact: denise johnson, rn ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4027792
• MDR Text Key: 20862766
• Report Number: 2648612-2014-00038
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 29AECS-602
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 55 YR