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

Model Number 25MJ-501

Device Problem Perivalvular Leak (1457)

Patient Problems Anemia (1706); Dyspnea (1816); Fatigue (1849)

Event Date 12/06/2022

Event Type  Injury  

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 (b)(6) 2009, a 19mm master's standard a ortic and 25mm mitral mit was reported that on (b)(6) 2009, a 19mm master's aortic mechanical heart valve and a 25mm masters mitral mechanical heart valve were successfully implanted.In (b)(6) 2022, the patient presented to the hospital with shortness of breath on exertion and fatigue.Since signs of heart failure were observed, the patient was managed with diuretics.In (b)(6) 2022 the patient visited the hospital again with elevated lactate dehydrogenase (ldh) of 1968 and hemolysis were confirmed.It was accompanied by anemia, and it was decided to perform a reoperation.Ultrasound showed paravalvular leak (pvl) in the mitral valve and 3.95 m/s in the aortic valve, indicating signs of aortic stenosis (as).On (b)(6) 2022, reoperation was performed and both the 19mm masters aortic valve and the 25mm masters mitral valve were explanted.No abnormalities were found in either valves.A new 19mm master's aortic mechanical heart valve and new 25mm masters mitral mechanical heart valve were implanted as replacements.Per the physician, the mitral valve had pvl and the aortic valve had as due to pannus; there was no problem with the valve itself.The patient was reported to be in stable condition.

Manufacturer Narrative

Explant due to hemolysis paravalvular leak and signs of aortic regurgitation was reported.The investigation found leaflets open and close completely were freely mobile, however slight limited mobility of one mechanical leaflet was noted.The investigation revealed fibrous pannus formation limited to sewing cuff, with calcification within it.There was focal chronic inflammation within the pannus.No acute inflammation was present.The cause of the reported incident could not be conclusively determined.

Event Description

N/a.

Manufacturer Narrative

Explant due to hemolysis, paravalvular leak and anemia was reported.The investigation found leaflets open and close completely were freely mobile, however slight limited mobility of one mechanical leaflet was noted.The investigation revealed fibrous pannus formation limited to sewing cuff, with calcification within it.There was focal chronic inflammation within the pannus.No acute inflammation was present.The cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

Explant due to hemolysis, paravalvular leak and anemia was reported.The investigation found leaflets open and close completely were freely mobile, however slight limited mobility of one mechanical leaflet was noted.The investigation revealed fibrous pannus formation limited to sewing cuff, with calcification within it.There was focal chronic inflammation within the pannus.No acute inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined.

• Brand Name: MASTERS SERIES 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: 16131208
• MDR Text Key: 307006505
• Report Number: 2135147-2023-00145
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006354
• UDI-Public: 05414734006354
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2014
• Device Model Number: 25MJ-501
• Device Catalogue Number: 25MJ-501
• Device Lot Number: 2824686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2009
• 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
• Patient Age: 65 YR
• Patient Sex: Female