MAUDE Adverse Event Report: ST. JUDE MEDICAL SJM REGENT HEART VALVE W/FLEX CUFF

Model Number 21AGFN-756

Device Problem Insufficient Information (3190)

Patient Problems Corneal Pannus (1447); Abscess (1690); Aortic Regurgitation (1716); Endocarditis (1834); Unspecified Infection (1930); Transient Ischemic Attack (2109)

Event Date 01/07/2014

Event Type  Injury  

Event Description

The information provided to sjm indicated a female patient underwent aortic valve replacement and ascending aortic replacement with a 21mm sjm regent valve with flex cuff (model: 21agfn-756, serial: (b)(4)) in 2004.In late 2013, the patient went to wakefield hospital presenting with a transient ischemic attack (tia).At this time aortic regurgitation was observed and later confirmed with an echocardiogram.The physician believed endocarditis to be present on the valve, but subsequent blood cultures revealed no infection.On (b)(6) 2013, the consulting physician recommended explanting the valve.The patient returned to the hospital on (b)(6) 2014 for testing and the valve was explanted on (b)(6) 2014; a non-sjm bioprosthesis was implanted.During the procedure, some pannus growth was observed on the valve.After inspecting the annulus, one of the pledgets was infected and an abscess was observed.The patient is stable following the procedure.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• Manufacturer (Section D): ST. JUDE MEDICAL; caguas PR
• Manufacturer Contact: denise johnson, rn ; lot 20 b st.; p.o. box 998; caguas, PR 00725 ; 6517564470
• MDR Report Key: 3631988
• MDR Text Key: 19296541
• Report Number: 2648612-2014-00006
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P810002/S057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2008
• Device Model Number: 21AGFN-756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2003
• 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: 61 YR