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

Model Number TF-23A

Device Problems Gradient Increase (1270); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2014

Event Type  Injury  

Event Description

The valve was explanted due to leakage and an elevated gradient.During the explant procedure, calcification was observed on the valve.Culture results indicated methicillin resistant coagulase negative staphylococcus.A 19 mm sjm mechanical regent valve was implanted as a replacement.The patient was reported to be stable postoperatively.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The results of this investigation concluded there were numerous calcific nodules on the inflow and outflow surfaces and within the cuspal tissue of each cusp.There was also organizing fibrin thrombus on the inflow and outflow surfaces of cusp 1.Special stains were negative for organisms, and no acute inflammation was observed on the cusps.There was no evidence found to suggest the cause of the calcific nodule and thrombus 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 calcific nodule and thrombus formation remains unknown.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 3131 0-26; BR 31310-260
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 3131 0-26; BR 31310-260
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4225049
• MDR Text Key: 5073762
• Report Number: 3001883144-2014-00026
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PP100029
• 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: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2014
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 3810915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2012
• 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: 69 YR