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

Catalog Number UNK MECHANICAL HEART VALVE

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 07/01/1978

Event Type  Injury  

Event Description

The article, "thirty year outcomes of low intensity anticoagulation for mechanical aortic valve", was reviewed.The article presented a retrospective, single center study to evaluate the long-term outcomes of low-intensity anticoagulation therapy after aortic valve replacement (avr) with a mechanical prosthesis.The devices included in this study were sjm mechanical valves.The article concluded that low-intensity anticoagulant therapy with an inr value of 1.6¿2.5, for selected patients with sinus rhythm after avr with bileaflet mechanical valve, is safe and effective, and very low inr of < 2.0 was not a significant risk factor for cardiac events, even in the long-term period, i.E., over 30 years.Further studies are required to consider appropriate anticoagulation for a large population, including patients with older age and atrial fibrillation.[the primary and corresponding author was shintaro sawa, department of cardiovascular surgery, tokyo women¿s medical university, 8-1 kawada, shinjuku, tokyo 162-8666, japan, with corresponding email: sawa.Shintaro@twmu.Ac.Jp].The time frame of the study was from july 1978 to december 2012.A total of 519 patients were included in this study, of which all received an abbott device.The average age was 53.1 years and the gender majority was male.Comorbidities included aortic regurgitation, aortic stenosis, infective endocarditis.

Manufacturer Narrative

D4 - the udi number is not known as the part and lot numbers were not provided.The additional patient effect of death reported in the article is captured under a separate medwatch report.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

D4 - the udi number is not known as the part and lot numbers were not provided.The additional patient effect of death reported in the article is captured under a separate medwatch report.Summarized patient outcomes/complications of mechanical heart valve reported in a research article in a subject population with multiple co-morbidities including aortic regurgitation (ar), aortic stenosis (as), aortic stenosis and regurgitation (asr), and infective endocarditis (ie).Some of the peri-procedural and post-procedural complications reported were surgical intervention (reoperation), thrombosis, embolism, bleeding, and death; 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 available information, the root cause of the reported event could not be conclusively determined.

• 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: 18924668
• MDR Text Key: 337913907
• Report Number: 2135147-2024-01213
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• 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
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• 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