MAUDE Adverse Event Report: ST. JUDE MEDICAL, PUERTO RICO, INC. SJM REGENT HEART VALVE W/FLEX CUFF; REGENT ROTATABLE VALVE

Model Number 19AGFN-756

Device Problem Incomplete Coaptation (2507)

Patient Problems Aortic Insufficiency (1715); Cardiac Arrest (1762); Thrombosis (2100)

Event Date 03/26/2014

Event Type  Injury  

Event Description

The pt underwent an aortic valve replacement procedure in (b)(^) 2012 where this valve was implanted.Recently, the pt arrested at home and cardiopulmonary resuscitation was performed.The pt was transferred to the hospital.Echocardiography revealed aortic insufficiency with the leaflets open in the vertical position due to valve thrombosis.Thrombolytic therapy was administered and the aortic insufficiency was resolved with the leaflets opening and closing normally.The pt's hypercoagulable workup was negative.Cardiologists requested a replacement be performed.The valve was explanted and replaced with an 18 mm mechanical valve from another mfr.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• Type of Device: REGENT ROTATABLE VALVE
• Manufacturer (Section D): ST. JUDE MEDICAL, PUERTO RICO, INC.; caguas PR
• Manufacturer Contact: denise johnson, rn ; 177 east county road b; st. paul, MN 55117 ; 6517564470
• MDR Report Key: 3763276
• MDR Text Key: 22142729
• Report Number: 2648612-2014-00018
• 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: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2016
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2011
• 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: 51 YR