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

Catalog Number UNK REGENT HEART VALVE

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

Patient Problems Stroke/CVA (1770); Heart Block (4444)

Event Date 05/20/2023

Event Type  Injury  

Manufacturer Narrative

B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided summarized patient outcomes/complications of mhv - regent (mechanical heart valve) were reported in a research article in a subject population with multiple co-morbidities including severe aortic stenosis and moderate aortic regurgitation.Some of the complications reported were stroke, unexpected medical intervention, heart block, and surgical intervention; 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The article, "aortic valve replacement in small aortic root- bi-leaflet mechanical valve is superior to a mono-leaflet mechanical valve", was reviewed.The article presented a retrospective, single center study to compare early and midterm outcomes following aortic valve replacement (avr) with a mono-leaflet (ml) valve and a bi-leaflet (bl) valve in a small aortic root.Devices included in the study were ttk chitra valve (mono-leaflet/ ml group) or st.Jude medical valve (bi-leaflet/ bl group).The article concluded that aortic valve replacement without any root widening procedure, using a small-sized mechanical valve provides acceptable early outcomes.Bi-leaflet mechanical valves provide better hemodynamics and survival percentage.The primary and corresponding author was (b)(6).The time frame of the study was from 01 january 2017 to 31 december 2019.A total of 98 patients were included in this study, of which 56 received an abbott device.The average age was 53.38 years in the ml group and 53.52 years in the bl group.The average gender was male.Comorbidities included severe aortic stenosis and moderate aortic regurgitation.Peri- and post-procedural complications included stroke, permanent pacemaker implant (surgical intervention), heart block, intra-aortic balloon pump support (unexpected medical intervention.

• Brand Name: REGENT 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: 18030342
• MDR Text Key: 326860161
• Report Number: 2135147-2023-04756
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK REGENT HEART VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• 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): Life Threatening; Disability; Required Intervention