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

Model Number TF-25A

Device Problems Backflow (1064); Gradient Increase (1270); Obstruction of Flow (2423)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Chest Pain (1776)

Event Date 03/11/2020

Event Type  Injury  

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.

Event Description

On (b)(6) 2013, a 25mm sjm trifecta valve was successfully implanted in the patient.The patient developed an acute coronary syndrome and was treated with a percutaneous coronary intervention (pci) on the circumflex ramus and its posterolateral branch in (b)(6) 2018 and it became known that the patient had severe hypertriglyceridemia.In the beginning of (b)(6) 2020, the patient showed clinical infarct symptoms with chest pain and a troponin movement in the laboratory.Suspicion of nstemi was expressed and the patient was coronary angiographed.Moderate aortic insufficiency (ai) and severe stenosis with an average pressure gradient of 50mmhg and a max pressure gradient of 78mmhg was observed.This was a change compared to the past follow-up checks that showed no leakage with deep gradients less then 10mmhg.On (b)(6) 2020, echo confirmed severe dysfunction of the prosthesis and on (b)(6) 2020, the valve was explanted from the patient and replaced with a 23mm trifecta¿ gt valve.The patient remained stable throughout the procedure and there was no clinically significant delay in the procedure.

Manufacturer Narrative

Explant was reported due to insufficiency and stenosis.The investigation found that all three leaflets contained calcifications and tears or incisions.There was fibrous pannus ingrowth on the outflow surface of leaflet 2.No inflammation 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 tears were associated with calcifications.The calcifications noted could have contributed to the reported stenosis.

• 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
• MDR Report Key: 10017624
• MDR Text Key: 189979564
• Report Number: 3008452825-2020-00212
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052047
• UDI-Public: 05414734052047
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/08/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2015
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: 4025296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 05/01/2020
• Supplement Dates Manufacturer Received: 05/29/2020
• Supplement Dates FDA Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 106