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); Unspecified Infection (1930); Pericardial Effusion (3271)
Date of Event	03/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: crd_992 - valved grafts pas, patient site id: (b)(6) (r749173601).It was reported that on (b)(6) 2023, a 23mm sjm masters series valsalva aortic valved graft was successfully implanted.On (b)(6) 2023, a slight leak was seen from the sternotomy wound and it was confirmed the patient had an infection.On (b)(6) 2023, antibiotic was administered.On (b)(6) 2023, slight leakage of serious turbid content was observed.On (b)(6) 2023, a surgical chest sheathing was performed to revise the wound site.Two units of red blood cells were administered.On (b)(6) 2023, a transthoracic echocardiogram (tte) was performed, and a trace of fluid was seen in the pericardial sac.Warfarin was restarted.On (b)(6) 2023, tte showed fluid in the pericardial sac up to 10mm at the rv/lv lateral and posterior walls; in the left pleural cavity, up to 25mm of fluid was also observed.The pericardial effusion did not lead to tamponade.The fluid in the pericardial sac was believed to be procedure related.The patient continued to be monitored in the study.
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 pericardial effusion 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 specifications.
Additional Manufacturer Narrative
Additional information: b5, h6, h10 an event of pericardial effusion 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 specifications.
Event or Problem Description
Clinical information: crd_992 - valved grafts pas, patient site id: pl5012 - 199 (r749173601, r754286001) subsequent to the initially filed report, the following information was received that the patient had a low hemoglobin of 7.6 g/dl on (b)(6)2023.The patient's hemoglobin improved on 12 march 2023 to 9.6g/dl and increased to 10.3 g/dl on 16 march 2023.No additional information was provided.

• 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: 16825689
• Report Number: 2135147-2023-01858
• Device Sequence Number: 6858528
• 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,Followup
• Report Date (Section B): 07/28/2023

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: 10/01/2023
• Device Model Number: 23VAVGJ-515
• Device Catalogue Number: 23VAVGJ-515
• Device Lot Number: 8261327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 05/17/2023; 07/05/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 05/23/2023; 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2021
• 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; Other; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Race: White