MAUDE Adverse Event Report: ABBOTT MEDICAL UNKNOWN MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Catalog Number UNK MECHANICAL HEART VALVE

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

Patient Problems Arrhythmia (1721); Ventricular Fibrillation (2130); Heart Failure/Congestive Heart Failure (4446)

Event Date 04/01/2020

Event Type  Injury  

Event Description

The article, "prognostic value of high sensitive troponin t in patients with severe aortic stenosis undergoing valve replacement surgery", was reviewed.The article presented a prospective, single center study to assess the prognostic value of highsensitive troponin t (hs-tnt) in symptomatic patients with severe aortic stenosis (as) and preserved left ventricular ejection fraction (lvef) after surgical aortic valve replacement (avr).Devices included in this study were st jude mechanical aortic valve (st.Jude medical, inc., usa), sorin (sorin group, livanova, italy), and medtronic (medtronic, usa).The article concluded hs-tnt is associated with bad short-term prognosis after avr.Hs-tnt and gls could be significant predictors for future mace in patients with severe symptomatic as and preserved lvef who underwent avr.Elevated hs-tnt and impaired gls could set an indication of early intervention in asymptomatic severe as.[the primary and corresponding author was mohammad eltahlawi, cardiology department, zagazig university, zagazig, egypt, with corresponding email: meltahlawi@medicine.Zu.Edu.Eg].

Manufacturer Narrative

Summarized patient outcomes/complications of prognostic value of high sensitive troponin t in patients with severe aortic stenosis undergoing valve replacement surgery were reported in a research article in a subject population with multiple co-morbidities including aortic stenosis, dyspnea, chest pain, pre-syncope/syncope.Some of the complications reported were readmission (hospitalization), congestive heart failure, arrhythmia, ventricular tachycardia these complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.Literature attachment: article title: prognostic value of high sensitive troponin t in patients with severe aortic stenosis undergoing valve replacement surgery na.

• Brand Name: UNKNOWN MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18150513
• MDR Text Key: 328302497
• Report Number: 2135147-2023-05058
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK MECHANICAL HEART VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• 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