MAUDE Adverse Event Report: ABBOTT MEDICAL SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number UNK SJM TRIFECTA VALVE

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2016

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: article title "thrombocytopenia among patients undergoing aortic valve replacement using the sutureless perceval s bioprosthesis.".

Event Description

The article "thrombocytopenia among patients undergoing aortic valve replacement using the sutureless perceval s bioprosthesis" was reviewed.The article presented a restrospective single center study, to compare the incidence, severity, and clinical implications of thrombocytopenia after aortic valve replacement (avr) using the perceval s or the trifecta bioprosthesis.Abbott devices used included the trifecta aortic valve.The article concluded that the perceval s bioprosthesis was associated with more severe postoperative thrombocytopenia.[the primary author and corresponding author was matthias kirschwith corresponding email matthias.Kirsch@chuv.Ch.The time frame of the study was march 2016 to august 2019.A total of 156 patients were included in this study, of which 53 received an abbott device.Comorbidities include previous myocardial infarction, congestive heart failure, diabetes, hypertension, hypercholesterolemia, chronic obstructive pulmonary disease, cerebrovascular arteriopathy, lower extremity arterial disease, previous valve replacement, aortic regurgitation, and bicuspid aortic valve.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18922978
• MDR Text Key: 337890658
• Report Number: 2135147-2024-01195
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SJM TRIFECTA VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• 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): Death