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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Endocarditis (1834); Renal Failure (2041); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, complications from having a trifecta valve implanted included patient prothesis mismatch, stenosis, regurgitation, calcifications, endocarditis, reoperation, cardiovascular disease, renal failure, prosthetic valve dysfunction, congenital valve findings and readmission to the hospital.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturing reference number: 3001883144-2021-00099, 2648612-2021-00071.The article, patient-prosthesis mismatch and surgical aortic valve replacement outcomes: retrospective analysis of single-center surgical data", was reviewed.This research article presents a retrospective single center experience to analyze the risk factors for patient-prosthesis mismatch (ppm) and the effects of ppm on early postoperative outcomes after surgical aortic valve replacement (savr).Carbomedics mitroflow, carpentier-edwards(ce) magna, ce magna ease, ce pericardial, ce pericardial perimount, edwards prima plus, medtronic freestyle medtronic mosaic, sorin perceval, sjm epic, sjm epic supra, sjm stentless porcine valve, sjm trifecta, sjm mechanical valve, bjork-shiley monostrut, carbomedics mechanical and medtronic-hall valves were associated to the study.The article concluded that higher body mass index (bmi), female sex, and bioprosthetic valves, especially the sjm epic valve, were associated with increased rates of ppm and severe ppm.The primary and correspondence author of the article is aurinjoy gupta, 2196 falconcrest dr, thunder bay, on p7j1h5, canada with the corresponding email augupta@nosm.Ca.

• Brand Name: TRIFECTA STENTED TISSUE 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: 12054630
• MDR Text Key: 258110797
• Report Number: 3014918977-2021-00021
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 68 YR