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

Catalog Number UNK MECHANICAL HEART VALVE

Device Problems Patient Device Interaction Problem (4001); Device Stenosis (4066)

Patient Problems Low Blood Pressure/ Hypotension (1914); Mitral Valve Stenosis (1965); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 08/15/2023

Event Type  Injury  

Manufacturer Narrative

D4 - the udi number is not known as the part and lot numbers were not provided.An event of prosthetic valve thrombosis and central regurgitation was reported through a research article.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or additional patient information was received for analysis.Based on the available information, the root cause of the prosthetic valve thrombosis and central regurgitation could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

The article, "dual mechanical valve thrombosis resolution through thrombolytics: a case series", was reviewed.The article presented a case study of a 43-year-old female with dyspnea at rest and a history of bacterial endocarditis and prior mitral valve repair procedure.It was reported that on an unknown date, a 25mm unknown st.Jude mechanical valve and a 21mm unknown st.Jude mechanical valve were implanted in a patient's mitral valve and aortic valve, respectively.It was reported a year post-procedure, the patient had temporarily paused their warfarin therapy for a dental procedure.A follow up transthoracic echocardiography noted a left ventricular ejection fraction of 55%, newly reduced right ventricular function, and an increased mean gradient across the mitral valve.It was also noted the prosthetic aortic valve also had moderate valvular regurgitation.Cine-fluoroscopy confirmed evidence of dual prosthetic valve thrombosis (pvt).The patient was administered intravenous norepinephrine for hypotension due to cardiogenic shock.The patient was treated with slow infusion of tissue plasminogen activator (tpa) followed by valvuloplasty two weeks later to resolve pvt.Patient status was reported as stable.The article concluded that dual mechanical pvt is a rare but serious complication of mechanical valve replacement, and its management should include multi-disciplinary discussion individualized to each patient¿s unique risk factors.Patients with obstructive symptoms and high surgical risk or who opt for medical therapy should undergo thrombolysis.Low-dose and slow or ultra-slow tpa infusion should be considered for those with high bleeding risk and can be safe even with elevated inr.Thrombosis may continue to resolve over weeks after thrombolysis, and percutaneous intervention may be considered for refractory valve dysfunction.[the primary author was colin mcguire, department of medicine, georgetown university hospital, washington, dc, usa.The corresponding author was benjamin kenigsberg, division of cardiology, medstar washington hospital center, 110 irving st., nw, washington, dc, usa, with corresponding email: (b)(6).

Manufacturer Narrative

An event of prosthetic valve thrombosis and central regurgitation was reported through a research article.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or additional patient information was received for analysis.Based on the available information, the root cause of the prosthetic valve thrombosis and central regurgitation could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 17835702
• MDR Text Key: 324499888
• Report Number: 2135147-2023-04228
• 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: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• 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: 09/12/2023
• 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: 43 YR
• Patient Sex: Female