MAUDE Adverse Event Report: ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA) TRIFECTA STENTED TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number CVD0027

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Insufficiency (1715); Cusp Tear (2656)

Event Date 10/14/2014

Event Type  Injury  

Event Description

A trifecta valve was implanted uneventfully 2.5 years ago.Recently, the patient presented to the emergency room with sudden aortic insufficiency and an acutely-torn cusp identified via echo.The patient was referred for open-heart surgery where the valve was explanted and a non-sjm valve was implanted.

Manufacturer Narrative

Gtin and manufacturing site: since the sn was not available, the gtin could not be provided and the manufacturing site confirmed.The results of this investigation are inconclusive because the product was not returned for analysis and the sn was not available which prevented a review of the device history record.The cause of the reported event remains unknown.

• Brand Name: TRIFECTA STENTED TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; belo horizonte 3400 0-00; BR 34000-000
• Manufacturer (Section G): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; belo horizonte 3400 0-00; BR 34000-000
• Manufacturer Contact: 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4234466
• MDR Text Key: 4977635
• Report Number: 3001743903-2014-00053
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: PP100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2014

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: Physician
• Device Model Number: CVD0027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2014
• Initial Date FDA Received: 11/07/2014
• 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 Outcome(s): Required Intervention