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

Model Number TF-25A

Device Problems Obstruction of Flow (2423); Material Split, Cut or Torn (4008)

Patient Problem Fatigue (1849)

Event Date 12/06/2021

Event Type  Injury  

Event Description

It was reported on an unknown date a trifecta stented tissue valve was implanted.The patient presented with fatigue and on (b)(6) 2021, the valve was explanted due to stenosis and upon explant the cuff and a leaflet was torn.A non-abbott valve was implanted.The patient was reported to be in unstable condition.Operative notes and echo images were requested but cannot be provided.Additional information has been requested but has not been obtained.

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Manufacturer Narrative

Explant due to an stenosis was reported.The investigation found that all three leaflets were torn.Leaflets 1 and 3 had fibrous thickening and calcifications.There was fibrous pannus ingrowth on the inflow surface of leaflets 1 and 3.No inflammation or significant calcification was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the tears could not be conclusively determined; however, the fibrous pannus ingrowth noted had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tears and reduced durability.

• 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: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13043040
• MDR Text Key: 282492435
• Report Number: 3007113487-2021-00116
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052047
• UDI-Public: 05414734052047
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 04/24/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2018
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: BR00007180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 04/11/2022
• Supplement Dates FDA Received: 04/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2016
• 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