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 01/01/2001

Event Type  Death  

Manufacturer Narrative

Summarized patient outcomes/complications of surgical aortic valve replacement (savr) to validate the roles of prosthesis-patient mismatch (ppm) and valve size were reported in a research article ¿association of valve size and hemodynamic performance with clinical outcomes in aortic valve replacement¿, in a subject population with multiple co-morbidities including smoking, aortic stenosis, aortic regurgitation, mitral regurgitation, tricuspid regurgitation, hypertension, diabetes, hyperlipidemia, coronary arterial disease, atrial fibrillation, chronic obstructive pulmonary disease, liver cirrhosis, chronic kidney disease, infective endocarditis, rheumatic heart disease, gout, malignancy, prior stroke, prior myocardial infarction, gastrointestinal bleeding, intracranial hemorrhage, major bleeding event, heart failure hospitalization.Some of the complications reported were death, redo aortic valve repair (surgical intervention), all-cause readmission (hospitalization), infective endocarditis, heart failure, aortic stenosis; 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 analysisna.

Event Description

The article, ¿association of valve size and hemodynamic performance with clinical outcomes in aortic valve replacement¿, was reviewed.The article presented a retrospective, single center study analyzing a large asian cohort with long-term follow-up hemodynamic and clinical outcome data after surgical aortic valve replacement (savr) to validate the roles of prosthesis-patient mismatch (ppm) and valve size.Devices included in this study were hancock ii, st jude epic, sav, trifecta, mosaic, magna ease/perimount, and unknown.The article concluded that relative to those receiving larger valves, patients receiving small bioprosthetic valves had poorer hemodynamic performance but did not demonstrate differences in clinical events in long-term follow-up.[the primary and corresponding author was shao-wei chen, chang gung memorial hospital, linkou medical center, chang gung university, no.5 fuxing street, guishan district, taoyuan city 33305, taiwan, with corresponding email: josephchen0314@gmail.Com].The time frame of the study was from 01 january 2001 to 31 december 2018.A total of 695 patients were included in the study, of which 390 (56.2%) received an abbott device.The average age was 66.8 years, the average weight was 62.0 kg, and the average gender was male.Comorbidities included smoking, aortic stenosis, aortic regurgitation, mitral regurgitation, tricuspid regurgitation, hypertension, diabetes, hyperlipidemia, coronary arterial disease, atrial fibrillation, chronic obstructive pulmonary disease, liver cirrhosis, chronic kidney disease, infective endocarditis, rheumatic heart disease, gout, malignancy, prior stroke, prior myocardial infarction, gastrointestinal bleeding, intracranial hemorrhage, major bleeding event, heart failure hospitalization.

• 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: 18691734
• MDR Text Key: 335184689
• Report Number: 2135147-2024-00623
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P040021
• 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: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/30/2024
• 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