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

Model Number	25VAVGJ-515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Hemorrhage/Blood Loss/Bleeding (1888); Ventricular Fibrillation (2130); Thrombosis/Thrombus (4440)
Date of Event	02/24/2023
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: (b)(6).It was reported that on (b)(6) 2023, a 25mm sjm masters series valsalva aortic valved graft was selected for implant.During the procedure, the patient experienced an aortic tick requiring hemostasis control via reperfusion.The patient also went into ventricular fibrillation and required defibrillation.No concomitant cardiac procedures were performed.There were no intraprocedural device deficiencies noted.Post procedure on (b)(6) 2023, the patient had increased post-operative bleeding and required a re-thoracotomy and mediastinal revision.Blood clots were removed, residual blood was observed in the pericardial sac, the left pleural cavity was aspirated, and the patient was given a blood transfusion and plasma.Two bleeding sites were found and treated.Patient had anemia in the form of decreased hemoglobin and hematocrit due to bleeding.Further blood transfusions were given on (b)(6), (b)(6), and (b)(6) 2023.These events were life-threatening and required prolonged hospitalization.The patient was discharged from the hospital on (b)(6) 2023.
Additional Manufacturer Narrative
An event of ventricular fibrillation requiring defibrillation, increased post-operative bleeding was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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 MN 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16606319
• Report Number: 2135147-2023-01325
• Device Sequence Number: 6272145
• 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: 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): 05/30/2023

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: 04/30/2025
• Device Model Number: 25VAVGJ-515
• Device Catalogue Number: 25VAVGJ-515
• Device Lot Number: 8802631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2022
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Race: White