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

Model Number	25MTJ-503
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Codes	Endocarditis (1834); Fever (1858)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on 13 january 2018, a 25mm sjm masters series heart valve with teflon cuff was successful implanted.On (b)(6) 2023, the patient presented with infective endocarditis and a re-do procedure was performed.There was no particular problem due to it being a mechanical valve, but reoperation was performed because of para-valvular leak.The device was explanted and replaced with another 25mm sjm masters series heart valve with teflon cuff.No additional information was reported.
Event or Problem Description
It was reported that on (b)(6) 2018, a 25mm sjm masters series heart valve with teflon cuff was successful implanted.On (b)(6) 2023, the patient presented with infective endocarditis and a re-do procedure was performed.There was no particular problem due to it being a mechanical valve, but reoperation was performed because of para-valvular leak.The device was explanted and replaced with another 25mm sjm masters series heart valve with teflon cuff.Subsequent to the previously filed report, additional information was received that the patient had a fever due to the infective endocarditis.The patient does not have any history of endocarditis.The patient does not have a history an indwelling vascular catheter, intravenous drug use, recent dental work, or injury from a non-sterile object.The paravalvular leak is believed to have been a result of the infective endocarditis.The implanting physician believes that the cause of the endocarditis is due to a patient condition.The patient was stable at the time of report.
Additional Manufacturer Narrative
Explant due to perivalvular leak and endocarditis was reported.The investigation found that both leaflets were intact and opened and closed completely without difficulty.However, part of the sewing cuff was removed and what remained contained a small amount of tissue.There was no allegation of malfunction against the abbott device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received the cause of the reported incident could not conclusively be determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: MASTERS SERIES HEART VALVE WITH TEFLON CUFF
• Common Device Name: 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: 16704681
• Report Number: 2135147-2023-01536
• Device Sequence Number: 3584982
• Product Code: LWQ
• UDI-Device Identifier: 05414734053617
• UDI-Public: 05414734053617
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2022
• Device Model Number: 25MTJ-503
• Device Catalogue Number: 25MTJ-503
• Device Lot Number: 6022121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 59 KG