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

Model Number TF-23A

Device Problem Insufficient Information (3190)

Patient Problems Aortic Regurgitation (1716); Dyspnea (1816); Endocarditis (1834); Cusp Tear (2656)

Event Date 11/05/2014

Event Type  Injury  

Event Description

A patient presented three years post tissue valve implant with dyspnea and a new heart murmur.An echocardiogram confirmed severe aortic regurgitation.Suspected endocarditis was treated with vancomycin and gentamicin.A redo valve was required and at the time of explantation, one of the cusps of the tissue valve was ruptured at the commissure between the right and noncoronary cusp.A replacement 23mm edwards magna ease valve was implanted.The patient is stable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The results of this investigation concluded fibrous thickening of all cusps, tears in cusps 2 and 3, 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 tears 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 tears remains unknown.

• Brand Name: SJM TRIFECTA VALVE
• 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: 4355756
• MDR Text Key: 5145118
• Report Number: 3007113487-2014-00032
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2012
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 3278475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2010
• 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: 90