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 Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Thrombosis/Thrombus (4440); Heart Block (4444)

Event Date 01/01/1997

Event Type  Death  

Event Description

The article, ¿mechanical atrioventricular valve replacement in patients with single ventricle palliation¿, was reviewed.The article presented a retrospective single center study to examine the experience with atrioventricular (av) valve replacement in children with single ventricle circulations and assess the relationship between early postoperative ventricular function and clinical outcome.All devices in this study were an unknown st.Jude medical mechanical valve.The article concluded mechanical valve replacement carries significant morbidity and mortality risk.While it successfully salvages about half of patients with preserved ventricular function, careful consideration of alternative options should be made before embarking upon mechanical valve replacement.[the primary and corresponding author was osami honjo, the labatt family heart centre, the hospital for sick children, (b)(6) toronto, on m5g 1x8 canada, with corresponding email: (b)(6).

Manufacturer Narrative

Date of death is estimated.Date of event is estimated.The udi number is not known as the part and lot numbers were not provided.The additional patient effects reported in the articles are captured under a separate medwatch report.Summarized patient outcomes/complications of mechanical atrioventricular valve replacement in patients with single ventricle palliation were reported in a research article in a subject population with multiple co-morbidities including hypoplastic left heart syndrome, unbalanced atrioventricular septal defect, tricuspid atresia, right atrial isomerism, pulmonary atresia/intact ventricular septum, double outlet right ventricle.Some of the complications reported were death, thrombosis, hemorrhage, myocardial infarction.Post-procedural complications included heart block, permanent pacemaker (surgical intervention), stroke, thrombus, hospitalization 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.

• 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: 17896488
• MDR Text Key: 325226603
• Report Number: 2135147-2023-04397
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• 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: 09/14/2023
• 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): Death