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

Model Number TF-19A

Device Problems Backflow (1064); Calcified (1077); Obstruction of Flow (2423); Material Split, Cut or Torn (4008)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 12/10/2021

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2015, a 19mm trifecta valve was implanted in the patient's aortic position.On (b)(6) 2021, the patient presented to the hospital due to respiratory distress during exertion and was followed up for suspicion of takotsubo cardiomyopathy.In late (b)(6) 2021, severe aortic regurgitation (ar) was confirmed, which led to reoperation.It was reported that there was progress of aortic stenosis (as) in the follow-up last year; the peak velocity was 3.02m/s, but the patient was just being followed up.On (b)(6) 2021, echocardiography was performed, which showed the peak velocity was 4.38m/s; there were findings of severe as, but the findings of ar were stronger.On (b)(6) 2021, the trifecta valve was explanted.Upon explant, two leaflets had tears and the stent posts of the lcc/rcc and the rcc/ncc were torn.According to the surgeon, there was some calcification on the leaflets, but no pannus were observed.A non-abbott valve was successfully implanted.The patient was reported to be in stable condition.

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Manufacturer Narrative

Additional information sections: d9, h3, h6, h10.Explant was reported due to regurgitation and stenosis.Leaflets 2 and 3 were torn.Leaflet 3 had fibrous thickening and contained folds and calcifications.No acute inflammation was found.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, one of the tears was associated with calcifications.

• 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, costa rica 01897 -405; CS 01897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13169390
• MDR Text Key: 283258454
• Report Number: 3014918977-2021-00126
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: 05414734052016
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/14/2022

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: 06/15/2017
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 5153026
• 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: 12/20/2021
• Initial Date FDA Received: 01/05/2022
• Supplement Dates Manufacturer Received: 02/17/2022
• Supplement Dates FDA Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2015
• 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; Required Intervention; Hospitalization; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 49 KG