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

Model Number TF-23A-IDE

Device Problem Gradient Increase (1270)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758); Stenosis (2263); Complete Heart Block (2627); Cusp Tear (2656)

Event Date 09/24/2014

Event Type  Injury  

Event Description

Echocardiograms revealed elevated gradients and stenosis caused by calcification.Re-do aortic valve replacement and tricuspid valve repair was performed.During the explant procedure, stenosis and calcification were observed on the valve.A 23 mm pericardial valve from another manufacturer was implanted.A permanent pacemaker was implanted on (b)(6) 2014 due to complete heart block.The hospital's pathology report noted calcification, moderate pannus, an area consistent with a tear, and one cusp with limited mobility.It was reported the patient was discharged from the hospital.

Manufacturer Narrative

(b)(4).The results of this investigation concluded fibrous thickening of all cusps, nodular calcifications within the tissue of each cusp, fibrous pannus ingrowth on the outflow surface of cusps 2 and 3, and a tear in cusp 1.Special stains were negative for organisms, and no acute inflammation was present.There was no evidence found to suggest the cause of the fibrous thickening, pannus formation, calcification formation, and cuspal tear 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 fibrous thickening, pannus formation, calcification formation, and cuspal tear remains unknown.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL CANADA, INC.; 2550 blvd. vanier; st. hyacinthe J2S 6L7; CA J2S 6L7
• Manufacturer (Section G): ST. JUDE MEDICAL CANADA, INC.; 2550 blvd. vanier; st. hyacinthe J2S 6L7; CA J2S 6L7
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4213469
• MDR Text Key: 5153299
• Report Number: 8020430-2014-00011
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2009
• Device Model Number: TF-23A-IDE
• Device Catalogue Number: TF-23A-IDE
• Device Lot Number: 0002684687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2008
• 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: 61 YR
• Patient Weight: 78