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

Model Number	23VAVGJ-515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	03/03/2023
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
Clinical information: crd_992 - valved grafts pas, patient site id: pl5215 - 136 (r744149201) it was reported that on (*b)(6) 2023, a 23mm sjm masters series valsalva aortic valved graft was successfully implanted.On the same day post procedure, the patient experienced cardiac arrest in the form of pulseless electrical activity (pea).A coronary angiogram was performed and showed right coronary artery occlusion caused by clots.A percutaneous coronary intervention (pci) was performed, and a stent was placed to open the blocked right coronary artery.No patient consequences were reported.
Additional Manufacturer Narrative
An event of cardiac arrest was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Information from the field indicated that the patient had a history of hypercholesterolemia.Information from the field indicated that the patient was handed to perform coronagraphy, and rca occlusion was seen.The coronagraphy confirmed that the clots caused occlusion.However, based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 16704901
• Report Number: 2135147-2023-01546
• Device Sequence Number: 3667080
• Product Code: LWQ
• UDI-Device Identifier: 05414734009522
• UDI-Public: 05414734009522
• 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: 2023
• 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
• Report Date (Section B): 06/07/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: 23VAVGJ-515
• Device Catalogue Number: 23VAVGJ-515
• Device Lot Number: 8479712
• Was Device Available for Evaluation?: No
• 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: 06/06/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2022
• 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; Life Threatening; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 72 KG