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

Catalog Number UNK MECHANICAL HEART VALVE

Device Problems Incomplete Coaptation (2507); Patient Device Interaction Problem (4001); Device Stenosis (4066)

Patient Problems Hemorrhage/Bleeding (1888); Hypoxia (1918); Mitral Valve Stenosis (1965); Pulmonary Edema (2020); Movement Disorder (4412); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

Literature article: percutaneous treatment of mechanical mitral valve thrombosis b3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The article, "percutaneous treatment of mechanical mitral valve thrombosis", was reviewed.The article presented a case study of a 75-year-old female patient.It was reported that on an unknown date, a 25mm unknown abbott mechanical mitral valve was implanted.It was later reported on an unknown date, the patient presented with gait instability and dysarthria in the setting of non-adherence to coumadin.Brain magnetic resonance imaging (mri) revealed multiple acute punctate infarcts.Transthoracic echocardiogram (tte) showed severe mitral stenosis with mean gradient of 23mmhg at a heart rate of 87 beats per minute.Fluoro-cine reveled a fixed anterior disc or leaflet.Heparin drip was initiated for presumed thrombosis but the patient condition deteriorated with development of pulmonary edema, hypoxemia, and right ventricular dysfunction.Low dose tissue plasminogen activator, 25 mg of alteplase over 6 h, was administered but the patient developed significant epistaxis with mild reduction in gradient.A decision was made to perform percutaneous intervention.Transthoracic echocardiogram (tee) showed thrombus on both discs with one leaflet completely immobile.A catheter was used to repeatedly push on the immobile leaflet and embolic material was filtered via cerebral protection device placed on the right radial artery.The patient status was reported stable with no neurologic complications post-procedure.The article concluded that percutaneous treatment of mechanical mitral valve thrombosis is feasible and the risk of neurologic complications can be mitigated with the use of a cerebral embolic protection device.[the primary and corresponding author was mamoo nakamura, 127 s san vicente blvd pavilion suite a3600, los angeles, ca 90048, usa, with corresponding email: mamoo.Nakamura@cshs.Org].

Manufacturer Narrative

Literature article: percutaneous treatment of mechanical mitral valve thrombosis.As reported in a research article, percutaneous treatment of mechanical mitral valve thrombosis.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.

• 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: 18301104
• MDR Text Key: 330168915
• Report Number: 2135147-2023-05420
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• 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
• Date Manufacturer Received: 12/27/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female