MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-23A

Device Problem Malposition of Device (2616)

Patient Problem Aortic Regurgitation (1716)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

According to the article "surgical treatment of prosthetic valve endocarditis; tips of complete resection of infective tissue and valve replacement" (japanese journal of thoracic surgery 2015, 68 (11): 923-929, case 6), one of 15 patients implanted with valves between 2009-2014 received a 23mm trifecta tissue valve which required explant due to improper seating and grade 4 aortic regurgitation.

• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5216782
• MDR Text Key: 30976199
• Report Number: 3007113487-2015-00043
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2015
• 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