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

Model Number	TF-25A
Medical Device Problem Codes	Backflow (1064); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a 25mm sjm trifecta valve was implanted on (b)(6) 2013.During a follow-up visit in the clinic, aortic regurgitation (ar) was observed coming from the right coronary cusp (rcc).The ar jet flow reached the cardiac apex.On (b)(6) 2021 the patient underwent explant of the 25mm sjm trifecta valve, upon explant, a leaflet tear was observed.A non-abbott device was placed and the patient was stable throughout the procedure.No additional information has been provided.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Additional Manufacturer Narrative
Explant was reported due to "aortic regurgitation".The investigation found that leaflet 1 was torn.There was circumferential fibrous pannus ingrowth on the inflow surface.Leaflet 3 had calcification.There was no acute inflammation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Calcification is a known potential adverse event associated with bioprosthetic heart valves.Per the warnings section of the instructions for use artmt600099236 rev.A, "accelerated deterioration due to calcific degeneration of the valve may occur in:" "children, adolescents, or young adults", "patients with altered calcium metabolism (e.G., patients with hyperparathyroidism or chronic renal failure)" or "individuals requiring hemodialysis".The limited mobility of the leaflets and tears associated with calcifications, further exacerbated by the pannus ingrowth, is consistent with the insufficiency noted prior to explant.

• 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: 13254520
• Report Number: 3007113487-2022-00007
• Device Sequence Number: 4753443
• Product Code: LWR
• UDI-Device Identifier: 05414734052047
• UDI-Public: 05414734052047
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 03/11/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/21/2015
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: 4168251
• 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: 01/05/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2013
• 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: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 65 KG