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

Catalog Number UNK MECHANICAL HEART VALVE

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

Patient Problems Hemorrhage/Bleeding (1888); Heart Block (4444); Heart Failure/Congestive Heart Failure (4446)

Event Date 03/27/2023

Event Type  Injury  

Manufacturer Narrative

Literature review: "the impact of bicuspid aortic valve leaflet fusion morphology on the ascending aorta and on outcomes of aortic valve replacement.Date of event is estimated.The udi number is not known as the part and lot numbers were not provided.Summarized patient outcomes/complications of mechanical heart valves were reported in a research article in a subject population with multiple co-morbidities including bicuspid aortic valves, aortic stenosis, aortic insufficiency/regurgitation, and endocarditis.Some of the complications reported were extracorporeal membrane oxygenation (unexpected medical intervention), intra-aortic balloon pumping, low cardiac output (heart failure), reintervention due to bleeding, complete heart block, and permanent pacemaker (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, "the impact of bicuspid aortic valve leaflet fusion morphology on the ascending aorta and on outcomes of aortic valve replacement", was reviewed.The article presented a retrospective, single center study to analyze the impact of leaflet fusion pattern on aortic root diameter and outcomes in patients undergoing surgery for bicuspid aortic valve (bav) vs tricuspid aortic valve (tav) disease.Devices included in this study were carpentier-edwards perimount magna, st jude medical regent, st jude medical masters, and terumo valsalva gelweave-coated vascular graft.The article concluded that this study suggested that preoperative dilation of the ascending aorta is more common in patients with right-noncoronary (r/n) fusion than in patients with right-left (r/l) and tav but is not significantly different between all groups in the early follow-up period.R/l fusion was associated with an increased risk of preoperative presence of aortic stenosis.[the primary and corresponding author was mark ruzmetov, joe dimaggio children¿s hospital, hollywood, florida, with corresponding email: markruz@hotmail.Com] the time frame of the study was not confirmed.A total of 90 patients were included in this study, of which 10 received an abbott device.The average age was 51.5 and the average gender was male.Comorbidities included bicuspid aortic valves, aortic stenosis, aortic insufficiency/regurgitation, endocarditis.

• 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: 18753002
• MDR Text Key: 335931710
• Report Number: 2135147-2024-00797
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK MECHANICAL HEART VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/21/2024
• 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; Life Threatening