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

Model Number TF-27A

Device Problems Device Operates Differently Than Expected (2913); Torn Material (3024)

Patient Problems Aortic Regurgitation (1716); Cusp Tear (2656)

Event Date 03/18/2015

Event Type  Injury  

Manufacturer Narrative

The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.The results of this investigation concluded all three cusps were fibrotically thickened and cusp 1 contained a tear.Fibrous pannus ingrowth was observed on the inflow and outflow surfaces of cusps 2 and 3.Basophilic foreign material was observed on the inflow and outflow surfaces of all three cusps.Special stains were negative for calcium.There was no evidence of acute inflammation and gram stains were negative for organisms.No evidence was found to suggest the cause of the pannus formation and cuspal tear was 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 reported event remains unknown.

Event Description

On (b)(6) 2011, a 27mm trifecta tissue valve was implanted.Four years later, an acute heart murmur was detected and severe aortic regurgitation was identified.On (b)(6) 2015, the valve was explanted at explant it was noted that the left cusp was torn from the stent post.The patient was discharged to home after recovery.

Manufacturer Narrative

(b)(4).

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897 -405; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897 -405; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4661763
• MDR Text Key: 13481951
• Report Number: 3008452825-2015-00017
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100029
• 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: 03/20/2015

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: Physician
• Device Expiration Date: 06/14/2013
• Device Model Number: TF-27A
• Device Catalogue Number: TF-27A
• Device Lot Number: 3432572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2015
• Initial Date FDA Received: 04/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2011
• 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): Required Intervention
• Patient Age: 63 YR