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

Catalog Number UNK MECHANICAL HEART VALVE

Device Problems Off-Label Use (1494); Device Stenosis (4066)

Patient Problems Dyspnea (1816); Tricuspid Valve Stenosis (2113)

Event Date 04/04/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: article title revisiting echocardiographic features of prosthetic heart valves: the necessity of correct differentiation of mono-leaflet vs.Bileaflet mechanical heart valves in a case report d4: the udi number is not known as the part and lot number were not provided.

Event Description

The article, "revisiting echocardiographic features of prosthetic heart valves: the necessity of correct differentiation of mono-leaflet vs.Bileaflet mechanical heart valves in a case report", was reviewed.The article presented a case study of a 65-year-old female patient with prior mitral valve replacement with 27mm mono-leaflet björk¿shiley tilting-disk valve.It was reported that on an unknown date, a 31mm unknown st.Jude medical/abbott mechanical valve was chosen for an off label procedure for tricuspid valve replacement.It was then reported on an unknown date, during a routine one year follow visit, the patient was referred for comprehensive assessment of mechanical valves due to mild dyspnea.Echocardiography showed the tricuspid mean gradient of the st.Jude/abbott mechanical valve was 5.3mmhg.With no evidence of paravalvular leak.[the primary and corresponding author was arman soltani moghadam, department of cardiology, imam khomeini hospital complex, tehran university of medical sciences, keshavarz boulevard, tehran, iran, with corresponding email: arman91as@yahoo.Com].

Manufacturer Narrative

As reported in a research article, revisiting echocardiographic features of prosthetic heart valves: the necessity of correct differentiation of mono-leaflet vs.Bileaflet mechanical heart valves in a case report.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per regent mechanical heart valve, instructions for use, " indications: the sjm regent¿ mechanical heart valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic valve.This device may also be used to replace a previously implanted aortic prosthetic heart valve." this is considered as an off-label use of the device.However, it was unable to determine if the off-label use contributed to the reported incident.Therefore, a letter will not be provided to address the deviation from the ifu.Literature attachment: revisiting echocardiographic features of prosthetic heart valves: the necessity of correct differentiation of mono-leaflet vs.Bileaflet mechanical heart valves in a case report.

• 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: 19202500
• MDR Text Key: 341287104
• Report Number: 2135147-2024-01883
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IR
• 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: 05/22/2024

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?: Yes
• 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: 04/04/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/22/2024
• 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): Other
• Patient Age: 65 YR
• Patient Sex: Female