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

Catalog Number	19A-101
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2023
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 (b)(6) 1997, a 19mm sjm standard mechanical heart valve was implanted during an aortic valve replacement.On (b)(6) 2023, a transthoracic echocardiogram (tte) was performed, which showed that there was a functional issue with one or two of the leaflets.The patient was recommended to receive a valve replacement.The patient was scheduled for a computed tomography angiogram (cta) to assess the need for a valve replacement.The patient status was stable.
Additional Manufacturer Narrative
An event of functional issue with leaflet/s was reported.It was reported that the patient was recommended to receive a valve replacement.A more comprehensive assessment, including hydrodynamic testing and histopathological examination of the valve could not be performed as the device remains implanted and was not returned for analysis.No implant related factors could be confirmed from the information received from the field as information related to implant procedure was not provided.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
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17987133
• Report Number: 2135147-2023-04609
• Device Sequence Number: 20882803
• Product Code: LWQ
• UDI-Device Identifier: 05414734005838
• UDI-Public: 05414734005838
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1997
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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 Catalogue Number: 19A-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Female