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	Anemia (1706); Hemorrhage/Blood Loss/Bleeding (1888); Heart Failure/Congestive Heart Failure (4446)
Date of Event	05/18/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
An event of bleeding and patient death due to biventricular heart failure was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The valve was reported to be functioning as intended.Information from the field indicated that the event was classified as most likely to be related to the procedure and possibly related to inadequate cardioplegia.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
Clinical information: (b)(4), patient site id: (b)(6).It was reported that on (b)(6) 2022, a 23mm sjm masters series heart valsalva aortic valve graft was chosen for procedure.The device was implanted, and there were no device issues noted during or after procedure.Heparin was administered during procedure.When first attempting to remove the patient from extracorporeal circulation (ecc), it was noted on transesophageal echocardiogram (tee) that the patient had biventricular heart failure.The patient was placed on veno-arterial extracorporeal membrane oxygenation (va-ecmo).On (b)(6) 2022, the patient's hemoglobin was low, and major bleeding was noted due to the heart operation and anticoagulation therapy.Multiple transfusions of red blood cells, platelets, and plasma were given, and surgical re-operation was performed.The patient passed away on 20 may 2022 due to biventricular heart failure.The event has been classified as possibly related to inadequate cardioplegia, therefore this event is being conservatively reported.

• 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: 15220933
• Report Number: 2135147-2022-00758
• Device Sequence Number: 6672935
• Product Code: LWQ
• UDI-Device Identifier: 05414734009522
• UDI-Public: 05414734009522
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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
• Report Date (Section B): 08/12/2022

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: 12/31/2022
• Device Model Number: 23VAVGJ-515
• Device Catalogue Number: 23VAVGJ-515
• Device Lot Number: 7430980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2020
• 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: Death
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White