MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-21A

Device Problem Perivalvular Leak (1457)

Patient Problem No Information (3190)

Event Date 09/24/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of this investigation concluded fibrous pannus ingrowth on the inflow surface of all cusps, and a thin layer of fibrin on all cusps.Special stains were negative for organisms, and no acute inflammation or significant calcifications were present.There was no evidence found to suggest the cause of the fibrin and pannus formation were due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the fibrin and pannus formation remains unknown.

Event Description

The valve was explanted due to paravalvular leakage.

Manufacturer Narrative

(b)(4).

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4200423
• MDR Text Key: 13043673
• Report Number: 3007113487-2014-00026
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 09/24/2014

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: Health Professional
• Device Expiration Date: 01/07/2016
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 4436082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2014
• Initial Date FDA Received: 10/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2014
• 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: 82 YR
• Patient Weight: 80