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 Incompatibility (2682); Device Stenosis (4066)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Fatigue (1849)

Event Date 11/24/2022

Event Type  Injury  

Manufacturer Narrative

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.Literature attachment: stuck leaflets in prosthetic heart valves with different etiology and treatments.

Event Description

The article, "stuck leaflets in prosthetic heart valves with different etiology and treatments", was reviewed.The article presented a case study of a 74-year-old female patient with rheumatic heart valve disease.It was reported that on an unknown date in 1999, a 21mm unknown abbott/st jude aortic mechanical heart valve and 29mm unknown abbott/st jude mitral mechanical heart valve were chosen for concomitant aortic and mitral valve replacement procedure, respectively.It was then reported on an unknown date in 2018, the patient presented with dyspnea and decreased effort capacity.Transthoracic echocardiography (tte) showed increased aortic gradient of 88/55 mmhg.A transesophageal echocardiography (tee) could not confirm any thrombus in the aortic or mitral valves.It was noted the valve tissue was thickened around the aortic valve.The patient's international normalized ratio (inr) was within normal therapeutic range.A fluoroscopy revealed one of the aortic valve leaflets was stuck due to pannus overgrowth.Surgical intervention was recommended but the patient refused.A decision was made instead to closely monitor inr values and acetylsalicylic acid was added/administered.At a later unknown date during follow-up, the aortic gradient decreased to 57/34 mmhg in 3 years.Echocardiography and fluoroscopy revealed that the aortic valve leaflets' movements were nearly normal and unstuck.A cardiac computed tomography (ct) confirmed normal leaflet movements and pannus overgrowth.The article concluded that the stuck leaflet is a rare but potentially severe complication of prosthetic heart valve (phv).Tee, fluoroscopy, and cardiac ct are feasible and highly effective imaging modalities that can detect and make the differential diagnosis of etiology.Furthermore, the treatment might vary from medical follow-up to emergency surgery, depending on the etiological cause and the patient¿s clinical manifestation.[(b)(6)].

• 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: 18914947
• MDR Text Key: 337793085
• Report Number: 2135147-2024-01137
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• 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: 02/15/2024
• 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: 74 YR
• Patient Sex: Female