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

Model Number TF-27A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024)

Patient Problem Aortic Insufficiency (1715)

Event Date 11/30/2017

Event Type  Injury  

Event Description

On (b)(6) 2011, an aortic valve replacement was performed and this 27 mm trifecta valve was implanted.On (b)(6) 2017, the valve was explanted.The patient was reported to be in stable condition.

Manufacturer Narrative

Product evaluation: an event of valve explant was reported.Morphological and histopathological examination found leaflet 3 was torn, circumferential pannus ingrowth narrowing the inflow diameter and patchy fibrous pannus on the outflow surface of leaflets 1 and 3.No acute inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

Event Description

On (b)(6) 2011, an aortic valve replacement was performed and this 27 mm trifecta valve was implanted.On (b)(6) 2017, the valve was explanted.When the physician explanted the valve, a torn leaflet was observed.An edwards magna ease valve was implanted as the replacement.The patient was reported to be in stable condition.The implanting surgeon and the explanting surgeon were 2 different surgeons.

• 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 ; 6517564470
• MDR Report Key: 7148953
• MDR Text Key: 95857320
• Report Number: 3007113487-2017-00038
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2013
• Device Model Number: TF-27A
• Device Catalogue Number: TF-27A
• Device Lot Number: 3402029
• Other Device ID Number: 05414734052054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 95