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 Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Mitral Valve Stenosis (1965); Renal Failure (2041)

Event Date 01/01/2019

Event Type  Injury  

Event Description

The article, "early and mid-term outcomes of using the chimney technique in redo mitral valve replacement in patients with a small mitral annulus", was reviewed.The article presented a retrospective, single center study to present early experiences on the outcomes of redo mitral valve replacement (re-mvr) in a small mitral annulus with the use of the chimney technique.Devices included in the study were sjm tissue heart valve and medtronic hancock.The article concluded that the use of the chimney technique in small mitral valve re-mitral valve replacement results in larger valve sizes.Moreover, the mean gradients over the mitral valve are acceptable both intraoperatively and over time.[the primary and corresponding author was liang tao, asia heart hospital of wuhan university, wuhan 430022, china, with corresponding email: taoliangmd@sina.Com].The time frame of the study was from 2019 to 2020.A total of 77 patients were included in the study, of which 48 (62.3%) received an abbott device.The average age was 56.7 years and the average gender was female.Comorbidities included hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, stroke, prior myocardial infarction, coronary artery disease, atrial fibrillation, infective endocarditis, hypertrophic cardiomyopathy, prior cardiac surgery.

Manufacturer Narrative

Summarized patient outcomes/complications of redo mitral valve replacement (re-mvr) in a small mitral annulus with the use of the chimney technique were reported in a research article "early and mid-term outcomes of using the chimney technique in redo mitral valve replacement in patients with a small mitral annulus." in a subject population with multiple co-morbidities including hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, stroke, prior myocardial infarction, coronary artery disease, atrial fibrillation, infective endocarditis, hypertrophic cardiomyopathy, prior cardiac surgery.Some of the complications reported were included death, reoperation (surgical intervention) due to bleeding, acute kidney injury, dialysis, prolonged ventilation (unexpected medical intervention), stroke, temporary neurological impairment, atrial fibrillation, intra-aortic balloon pump, mitral valve 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 analysis.Literature attachment: article title: "early and mid-term outcomes of using the chimney technique in redo mitral valve replacement in patients with a small mitral annulus.".

• 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: 18608958
• MDR Text Key: 334143151
• Report Number: 2135147-2024-00412
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• 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: 01/05/2024
• 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): Required Intervention; Disability; Life Threatening