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

Model Number	21VAVGJ-515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Thrombosis/Thrombus (4440)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
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 21mm sjm masters series valsalva aortic valved graft was successfully implanted.No concomitant cardiac procedures were performed.There were no intraprocedural adverse events or device deficiencies.In the first post-operative hours, excessive mediastinal drainage was observed.Due to the increased drainage, another thoracotomy was performed.Bleeding was controlled.Blood clots were removed.Hospitalization was prolonged.The patient status was stable.
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 excessive mediastinal drainage, bleeding, thrombus and atrial fibrillation 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.
Event or Problem Description
Clinical information: (b)(6) - valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 21mm sjm masters series valsalva aortic valved graft was successfully implanted.No concomitant cardiac procedures were performed.There were no intraprocedural adverse events or device deficiencies.In the first post-operative hours, excessive mediastinal drainage was observed due to the procedure.The implanted valve was still working as intended, and the bleeding was not believed to be related to a device issue.Due to the increased drainage, another thoracotomy was performed.Bleeding was controlled.Blood clots were removed.Patient received red blood cell transfusion, plasma transfusion, fibrinogen concentrate, and tranexamic acid.On (b)(6) 2023, patient received another blood transfusion.Hospitalization was prolonged.On (b)(6) 2023, atrial fibrillation was noted.Anti-arrhythmic medications were administered.On (b)(6) 2023, the patient was admitted due to mobility of the sternum and the leakage of serious content from the wound.After antibiotic preparation and obtaining sterile cultures, the sternotomy wound was cleaned and sutured on (b)(6) 2023.The patient status was stable and discharged.

• 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: 16710637
• Report Number: 2135147-2023-01568
• Device Sequence Number: 1791897
• Product Code: LWQ
• UDI-Device Identifier: 05414734009478
• UDI-Public: 05414734009478
• 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): 06/18/2023

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: 05/31/2025
• Device Model Number: 21VAVGJ-515
• Device Catalogue Number: 21VAVGJ-515
• Device Lot Number: 8627073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 06/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Race: White