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

Catalog Number 21A-101

Device Problems Patient-Device Incompatibility (2682); Device Stenosis (4066)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 02/23/2024

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2000, a 27mm (b)(6) mechanical mitral valve and a 21mm (b)(6) mechanical aortic valve were both implanted during a double valve replacement.On a later date, it was noted that there was a mitral perivalvular leak (pvl) in a crescent shape.The perivalvular leak was causing hemolytic anemia.On (b)(6) 2024, a 12mmx3mm amplatzer valvular plug 3 was successfully implanted to treat the pvl.On (b)(6) 2024, it was noted via transthoracic echocardiography (tte) that the patient had elevated aortic gradients, right ventricular dilation, and right ventricular systolic pressure.There was noted to be a small degree of chronic pannus formation on the aortic valve that had been present for approximately 4 years.The patient status was reported as stable.

Manufacturer Narrative

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

Event Description

It was reported that on 21 september 2000, a 27mm st.Jude medical mechanical mitral valve and a 21mm st.Jude medical mechanical aortic valve were both implanted during a double valve replacement.In (b)(6) 2023, the patient had hemolytic anemia, which was believed to be due to a mitral perivalvular leak (pvl) in a crescent shape.On 23mm february 2024, a 12mmx3mm amplatzer valvular plug 3 was successfully implanted to treat the pvl.On (b)(6) 2024, it was noted via transthoracic echocardiography (tte) that the patient had elevated aortic gradients, right ventricular dilation, and right ventricular systolic pressure.There was noted to be a small degree of chronic pannus formation on the aortic valve that had been present for approximately 4 years.It was then reported that the patient had been experiencing aortic valve stenosis dating back to 2015.The patient status was reported as stable.

Manufacturer Narrative

An event of a small degree of chronic pannus formation on the aortic valve and aortic valve stenosis was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.The device serial number was not provided, and therefore the device history record could not be reviewed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: STANDARD 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: 18940449
• MDR Text Key: 338128631
• Report Number: 2135147-2024-01245
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21A-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2024
• 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
• Treatment: SJM MECHANICAL MITRAL HEART VALVE, 27M-101
• Patient Outcome(s): Other