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

Model Number TF-19A

Device Problem Gradient Increase (1270)

Patient Problem No Code Available (3191)

Event Date 11/18/2014

Event Type  Injury  

Event Description

The sjm trifecta valve was explanted due to high gradient and was replaced with a 19 mm mechanical heart valve from another manufacturer.At the time of the redo procedure, a coronary artery bypass and tricuspid annuloplasty were performed.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis; however, photos of the explanted valve were received from the field.There appeared to be dense granular tissue formation on portions of both the inflow and outflow surfaces of each cusp, and along each stent post.There appeared to also be white tissue formation on the visible sections of the sewing cuff, a tear or cut at the free edge of one of the cusps, and a tear or cut at the base of another cusp along the stent post.Due to the limited view of the device, no additional observations were able to be made.The device history record was reviewed, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 4334755
• MDR Text Key: 18040603
• Report Number: 3007113487-2014-00031
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/18/2014

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: 12/25/2012
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 3285897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2014
• Initial Date FDA Received: 12/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2010
• 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: 57 YR