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	Atrial Fibrillation (1729); Hemorrhage/Blood Loss/Bleeding (1888)
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: (b)(6).It was reported that on (b)(6) 2023, a 23mm sjm masters series valsalva aortic valved graft was chosen for implant.The patient's international normalized ratio (inr) was 1.00 at baseline.The graft was not pre-clotted.The patient was given 4500 ie of heparin in pre-op, and 115000 ie during the procedure.The device was successfully implanted.After the device was implanted and patient was being weaned off bypass, bleeding was observed dorsal to the right coronary artery (rca) on the rca anastomosis.Directly post procedure, the patient's inr was 1.22 and the patient's activated clotting time (act) was 412 seconds.A right coronary artery re-insertion surgery was emergently performed to treat the bleed.A total of three units (1807ml) of blood and/or blood products were administered due to this event.The patient continued to be followed in the clinical study.
Additional Manufacturer Narrative
An event of a bleeding observed dorsal to the right coronary artery (rca) on the rca anastomosis was reported.A returned device assessment could not be performed as the device was not returned for analysis.Information from the field indicate that heparin was administered during the procedure and the patient's act at the time of bleeding onset was 412.The field also indicated that the bleeding due to fragile tissue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined but could have been due to patient anatomy.
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 23mm sjm masters series valsalva aortic valved graft was chosen for implant.The patient's international normalized ratio (inr) was 1.00 at baseline.The graft was not pre-clotted.The patient was given 4500 ie of heparin in pre-op, and 115000 ie during the procedure.The device was successfully implanted.After the device was implanted and patient was being weaned off bypass, bleeding was observed dorsal to the right coronary artery (rca) on the rca anastomosis.Directly post procedure, the patient's inr was 1.22 and the patient's activated clotting time (act) was 412 seconds.A right coronary artery re-insertion surgery was emergently performed to treat the bleed.A total of three units (1807ml) of blood and/or blood products were administered due to this event.On (b)(6) 2023, the patient went into atrial fibrillation.Patient was administered amiodarone and had cardioversion.The patient continued to be followed in the clinical study.
Additional Manufacturer Narrative
An event of a bleeding observed dorsal to the right coronary artery (rca) on the rca anastomosis was reported.A returned device assessment could not be performed as the device was not returned for analysis.The field also indicated that the bleeding due to fragile tissue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined but could have been related to fragile tissue due to patient anatomy.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 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16950553
• Report Number: 2135147-2023-02167
• Device Sequence Number: 19658485
• Product Code: LWQ
• UDI-Device Identifier: 05414734009522
• UDI-Public: 05414734009522
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/09/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: 23VAVGJ-515
• Device Catalogue Number: 23VAVGJ-515
• Device Lot Number: 8509443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 07/07/2023; 09/15/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 07/18/2023; 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2022
• 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: Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Race: White