MAUDE Adverse Event Report: ST. JUDE MEDICAL TRIFECTA STENTED TISSUE VALVE

Model Number TF-19A

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Stenosis (2263); Complaint, Ill-Defined (2331)

Event Date 06/27/2014

Event Type  Injury  

Event Description

The information provided to sjm indicated a patient underwent an aortic valve replacement procedure implanting a 19mm trifecta valve due to severe aortic stenosis.A follow-up transthoracic echocardiogram revealed the right coronary cusp of the valve was immobile, and the left coronary cusp and non-coronary cusp appeared to be adhered at the commissure.The patient underwent a balloon aortic valvuloplasty on (b)(6) 2014, but the patient's condition became worse.The patient underwent a re-do aortic valve replacement and the trifecta valve was explanted and replaced with another manufacturer's smaller 18mm mechanical valve.All three cusps of the trifecta valve were reported to be stiffened.

• Brand Name: TRIFECTA STENTED TISSUE VALVE
• Type of Device: STENTED TISSUE VALVE
• Manufacturer (Section D): ST. JUDE MEDICAL; pampulha ; BR
• Manufacturer Contact: denise johnson, rn ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 3954788
• MDR Text Key: 4557086
• Report Number: 3001883144-2014-00014
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2015
• Device Model Number: TF-19A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2013
• 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: 78 YR