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

Model Number	29CAVGJ-514 00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pericardial Effusion (3271)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical study (b)(4) - valved grafts pas, patient id: (b)(6), site: (b)(6).This event is being conservatively reported as the cause of the bleeding was unknown during an emergency surgical surgery.It was reported that on (b)(6) 2022, a 29mm sjm masters series coated aortic valved graft was successfully implanted during an emergency surgery procedure.After disconnection from cardiopulmonary bypass, the patient had fluid blood content in the pericardial sac.The patient's activated clotting time (act) level was 615, and heparin was administered.The patient received two units of fresh frozen plasma (ffp) and two units of red blood cell concentrate.On (b)(6) 2022, a thoracotomy was performed under anesthesia at the endotracheal site.There was pericardial effusion without tamponade.There was fluid blood content and clots in the pericardial sac.Setonage was removed.Sutures applied on a small siding on the venous bypass to the right coronary artery.Follow up did not reveal any surgical bleeding points.The patient was discharged on (b)(6) 2022.As of (b)(6) 2022, the patient is stable.The cause of bleeding was unknown.No additional information was provided.
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 all specifications.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: MASTERS SERIES HEART COATED AORTIC VALVED 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: 14426994
• Report Number: 2135147-2022-00286
• Device Sequence Number: 6465512
• Product Code: LWQ
• UDI-Device Identifier: 05414734006514
• UDI-Public: 05414734006514
• 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: 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,Followup
• Report Date (Section B): 06/17/2022

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 Model Number: 29CAVGJ-514 00
• Device Catalogue Number: 29CAVGJ-514 00
• Device Lot Number: 8274354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2021
• 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: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White