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

Catalog Number UNK TISSUE HEART VALVE

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

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

Event Date 11/01/2007

Event Type  malfunction  

Event Description

The article, ¿long-term echocardiographic data, mechanisms of failure and reintervention outcomes of the epic¿ valve in mitral position ¿ a large observational cohort¿, was reviewed.The article presents a retrospective single center study experience to assess the mechanisms and independent predictors of epic failures and to compare short- and mid-term outcomes according to reintervention type.Devices mentioned in the study was epic, on-x, magna, unknown sjm/abbott mechanical valve, mitris resilia, sapien 3, and sapien xt.The article concluded the epic¿ mitral valve has stable hemodynamics through 5 years and was associated with low incidence of structural valve deterioration (svd) and reintervention mostly due to endocarditis and leaflet tear without calcification.Reintervention type had no influence on early outcomes and mid-term mortality.[ (b)(6).] the time frame of the article was from november 2007 to may 2021.A total number of 1397 patients were included in this study.The average age was 72 years and the average gender was male.Comorbidities included hypertension, dyslipidemia, coronary artery disease, atrial fibrillation, obesity, chronic kidney disease, smoking, chronic obstructive pulmonary disease, prior myocardial infarction, previous cabg/pci, cardiac failure, prior stroke/tia, endocarditis, regurgitation, and diabetes.

Manufacturer Narrative

Literature article: long-term echocardiographic data, mechanisms of failure and reintervention outcomes of the epic¿ valve in mitral position ¿ a large observational cohort.Summarized patient outcomes/complications long-term echocardiographic data, mechanisms of failure and reintervention outcomes of the epic¿ valve in mitral position ¿ a large observational cohort were reported in a research article in a subject population with multiple co-morbidities including hypertension, dyslipidemia, coronary artery disease, atrial fibrillation, obesity, chronic kidney disease, smoking, chronic obstructive pulmonary disease, prior myocardial infarction, previous cabg/pci, cardiac failure, prior stroke/tia, endocarditis, regurgitation, and diabetes.Some of the complications reported were death, stroke/tia, infection, bleeding, renal failure, pacemaker implant, atrial fibrillation, structural valve deterioration, endocarditis, thrombosis, mitral regurgitation, paravalvular leak, dyspnea these complications are anticipated for the procedure.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 TISSUE HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17494806
• MDR Text Key: 321643642
• Report Number: 2135147-2023-03490
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK TISSUE HEART VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2023
• 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