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

Model Number	TF-25A
Medical Device Problem Codes	Obstruction of Flow (2423); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Fatigue (1849)
Date of Event	12/06/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 3007113487-2021-00116
• Device Sequence Number: 20196109
• Product Code: LWR
• UDI-Device Identifier: 05414734052047
• UDI-Public: 05414734052047
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 04/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown