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

Catalog Number UNK MECHANICAL HEART VALVE

Device Problems Perivalvular Leak (1457); Patient-Device Incompatibility (2682); Central Regurgitation (4068)

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

Event Date 04/01/1990

Event Type  malfunction  

Manufacturer Narrative

The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: article title "benefits of on-x mitral valve replacement in cases of infective endocarditis".

Event Description

The article, "benefits of on-x mitral valve replacement in cases of infective endocarditis", was reviewed.The article presented a retrospective, single center study investigated the hemodynamic efficacy of the on-x valve when used for mitral valve replacement (mvr) in cases of mitral valve infective endocarditis (ie).Devices included in this study were on-x (on-x life technologies inc.) and unknown sjm mechanical heart valve (st jude medical/abbott).The article concluded that the suggested reduction in left atrial load attributed to the use of the on-x valve in mvr for ie may reduce the incidence of postoperative atrial fibrillation.[the primary and corresponding author was manabu shiraishi, department of cardiovascular surgery, saitama medical center, jichi medical university, saitama, japan, with corresponding email: (b)(6) ] the time frame of the study was from april 1990 and december 2022.A total of (b)(6) patients were included in this study, of which 27 (67.5%) received an abbott device.The average age was 54.1 years and the gender majority was male.Comorbidities included hypertension, dyslipidemia, diabetes mellitus, renal dysfunction, chronic obstructive pulmonary disorder, atrial fibrillation, previous cardiac surgery, infective endocarditis, heart failure, uncontrolled sepsis, systemic embolic event, mobile vegetation, severe mitral regurgitation.Peri- and post-procedural complications included death, surgical intervention, hospitalization, mitral regurgitation, atrial fibrillation, paravalvular leak, infective endocarditis, intracranial hemorrhage, stroke, heart failure, cardiac arrest, arrhythmia "death in the sjm group was due to intracranial hemorrhage (n=1), stroke (n=1), congestive heart failure (n=2), sudden cardiac arrest due to ventricular arrhythmia (n=1), or was sudden and of unknown cause (n=1).".

Manufacturer Narrative

Summarized patient outcomes/complications of mechanical heart valve were reported in a research article in a subject population with multiple co-morbidities including hypertension, dyslipidemia, diabetes mellitus, renal dysfunction, chronic obstructive pulmonary disorder, atrial fibrillation and previous cardiac surgery.Some of the complications reported were surgical intervention, hospitalization, mitral regurgitation, atrial fibrillation, paravalvular leak, infective endocarditis, intracranial hemorrhage, stroke, heart failure, cardiac arrest, arrhythmia and patient death.It was reported that patient death in the sjm group was due to intracranial hemorrhage, stroke, congestive heart failure, sudden cardiac arrest due to ventricular arrhythmia, or was sudden and of unknown cause.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.

• 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: 18915319
• MDR Text Key: 337844516
• Report Number: 2135147-2024-01146
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Life Threatening; Death; Disability; Required Intervention; Hospitalization