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

Catalog Number UNK MECHANICAL HEART VALVE

Device Problem Perivalvular Leak (1457)

Patient Problems Dyspnea (1816); Pleural Effusion (2010); Hemolytic Anemia (2279); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Pulmonary Hypertension (4460)

Event Date 08/17/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The article, "structures on the ventricular side of the prosthetic valve in extremely late mitral paravalvular leak: a case report", was reviewed.The article presented a case study of a 68-year-old female patient with rheumatic valve disease.It was reported on an unknown date, an unknown st.Jude medical mechanical valve was implanted in the patient's mitral valve and another unknown st.Jude medical mechanical valve was implanted in the patient's aortic valve.It was later reported on an unknown date about 29 years later, the patient presented with exertional dyspnea.Three months later on an unknown date, echocardiography detected paravalvular leak of the mitral valve and the patient continued to develop hemolytic anemia and dyspnea.It was then reported on an unknown date the patient presented to the hospital with congestive heart failure, heart murmur with orthopnea, and chest roentgenogram detected lung congestion and pleural effusion.Echocardiography revealed severe mitral regurgitation due to paravalvular leak leading to pulmonary hypertension.Imaging also revealed subvalvular pannus that caused aortic valve stenosis.The mitral valve prosthesis was also displaced 8-10mm higher due to a circular calcification.A decision was made to explant both aortic and mitral valves and replaced with an unknown valve and unknown epic valve, respectively.The replacement valves were implanted successfully with no adverse patient consequences and the patient status was reported as stable.The article concluded the structures on the ventricular side of the mitral valve in a late pvl could be visualized in an untouched condition.Not only the protruding circular calcification and displacement of the prosthetic valve to the atrial side but also the loss of adhesion and adhesive nature of the annular tissue played a definitive role in the late pvl occurrence and recurrence after percutaneous or surgical repair.[the primary and corresponding author was hiroyuki nakajima, department of cardiovascular surgery, international medical center, saitama medical university, 1397-1, yamane, hidaka, saitama 350-1298, japan, with corresponding email: hn00504@ybb.Ne.Jp].

Manufacturer Narrative

Summarized patient outcomes/complications of unknown mhv mitral valve was reported in a research article in a subject population with unknown co-morbidities.Some of the complications reported were paravalvular leak, dyspnea, congestive heart failure, hemolytic anemia, pleural effusion, mitral regurgitation, pulmonary hypertension, surgical intervention and hospitalization; these complications are anticipated for the procedure and subject population.Information from field indicated that there were no peri-procedural complications.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: 17847142
• MDR Text Key: 324630293
• Report Number: 2135147-2023-04250
• 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: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• 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: 10/02/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female