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

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

Patient Problems Aortic Regurgitation (1716); Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, complications from implantation of a surgical valve included stroke, bleeding complications, acute kidney injury, pacemaker implantation, atrial fibrillation, prolonged hospitalization, aortic regurgitation, and reintervention.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

The article, "performance of the heart team approach in daily clinical practice in high-risk patients with aortic stenosis", was reviewed.The research article is a prospective multi center experience to identify the factors associated with the heart team(ht) decision and evaluate clinical outcomes according to the treatment choice.Sapien xt(edwards), sapien 3 (edwards), corevalve(medtronic), evolut r (medtronic), portico (abbott), symetis(boston scientific), trifecta (abbott), mitroflow(sorin), perimount magna ease carpentier(edwards), intuity (edwards) were associated to the study.There is no allegation of malfunction of the abbott device.The article concluded that the ht decision was determined by well-recognized risk factors that were used to define a treatment decision algorithm.Future studies with younger and lower-risk patients may identify new contributory factors that may alter the selection process and treatment choice.The primary author of this article is gabriela tirado-conte, md, department of cardiology, cardiovascular institute, hospital clínico san carlos, idissc, madrid, spain.The corresponding author of the article is luis nombela-franco, md, department of cardiology, cardiovascular institute, hospital clínico san carlos, idissc, madrid, spain with the email luisnombela@yahoo.Com.

• Brand Name: TRIFECTA STENTED TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (SH); 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 (SH); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10916022
• MDR Text Key: 218647391
• Report Number: 3008452825-2020-00672
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 11/28/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 11/28/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 83 YR