MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT; HEART-VALVE, MECHANICAL

Model Number	25VAVGJ-515
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/14/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Clinical study patient id: (b)(6).It was reported that on (b)(6) 2022, a 25mm masters series mechanical heart valve was successfully implanted in a patient.Heparin was administered with an activated clotting time (act) of 433 seconds.On (b)(6) 2022, the patient had a surgical intervention due to small amounts of clots under the sternum and in the area of the right atrium.The clots were removed, and no bleeding spots noted.The patient's international normalized ratio (inr) closest to the time of the reported thrombus measured on (b)(6) 2022 was 1.93 and the last inr measured was 1.66.No hematologic disorders or systemic illness that could contribute to a hypercoagulability mentioned in the medical history of the patient.The patient was reported to be in stable condition.No additional information was provided.
Event or Problem Description
Clinical study patient id: (b)(6) it was reported that on (b)(6) 2022, a 25mm masters series mechanical heart valve was successfully implanted in a patient.Heparin was administered with an activated clotting time (act) of 433 seconds.On (b)(6) 2022, the patient had a surgical intervention due to small amounts of clots under the sternum and in the area of the right atrium.The clots were removed, and no bleeding spots noted.The patient's international normalized ratio (inr) closest to the time of the reported thrombus measured on (b)(6) 2022 was 1.93 and the last inr measured was 1.66.No hematologic disorders or systemic illness that could contribute to a hypercoagulability mentioned in the medical history of the patient.On (b)(6) 2023 a call was made to the patient and information received from the patient's wife about the death of the patient in another hospital on (b)(6) 2023.According to the wife, there were problems with blood pressure.The cause of the death is related to low blood pressure no other information about the cause of death.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of thrombus in the sternum and right atrium, as well as patient death related to low blood pressure was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated the patient did not have any hematologic disorders or systemic illness that could contribute to a hypercoagulability, and that their inr level was not low.It was indicated that the patient death was related to low blood pressure and was not related to the procedure or the device.The valve was reported to be working as intended.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 medical device problem code: code 4001 removed.

• Brand Name: MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT
• 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: 16269108
• Report Number: 2135147-2023-00327
• Device Sequence Number: 12392697
• Product Code: LWQ
• UDI-Device Identifier: 05414734009492
• UDI-Public: 05414734009492
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2023

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: 09/30/2024
• Device Model Number: 25VAVGJ-515
• Device Catalogue Number: 25VAVGJ-515
• Device Lot Number: 8491492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 02/16/2023; 03/21/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 03/16/2023; 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• 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; Death
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Race: White