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

Catalog Number	19CAVGJ-514 00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Shock (2072)
Date of Event	05/28/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2024, a 19mm sjm masters series coated aortic valved graft was implanted.It was reported that the graft material was hard in consistency and the suture points were not sealed properly, which led to bleeding even after hemostasis was achieved.Additional sutures were made, hemostatic agent was used, glue was used, and activated clotting time (act) level was maintained at 120 seconds.Blood transfusion and platelets were given.The patient died of cardiogenic shock 48 hours after the procedure on (b)(6) 2024.The issue with the device was reported to be with the graft tissue and not the valve itself.The valve was functioning appropriately.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
It was reported that the graft material was hard in consistency and the suture points were not sealed properly which led to bleeding even after hemostasis was achieved.There was significant intra-operative bleeding that was managed with blood transfusion and hemostatic agents including biological glue.The patient post-operatively developed cardiogenic shock and expired.A more comprehensive assessment could not be performed as the device remained implanted and was not returned for analysis.It is difficult to determine the cause for the reported hardness of the graft material and whether the reported post-operative cardiogenic shock was related to post-operative bleeding associated with suture holes through the graft.Based on the information received, the cause of the reported patient death 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.

• 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: 19666303
• Report Number: 2135147-2024-03226
• Device Sequence Number: 20559027
• Product Code: LWQ
• UDI-Device Identifier: 05415067044037
• UDI-Public: (01)05415067044037(17)271116(10)8765773
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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 Catalogue Number: 19CAVGJ-514 00
• Device Lot Number: 8765773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2022
• 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: Death
• Patient Age: 60 YR
• Patient Sex: Female