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

Model Number	25CAVGJ-514 00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Hemorrhage/Blood Loss/Bleeding (1888); Renal Failure (2041); Heart Block (4444)
Date of Event	03/08/2022
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
It was reported on (b)(6) 2022, a 25mm masters series aortic valve was implanted.Post procedure, the patient experienced a drop in hemoglobin.Two units of red blood cells (rbc) were given on (b)(6) 2022, and two units of rbc were given on (b)(6)2022.The source of the bleeding was not provided.On (b)(6) 2022, the patient had an acute kidney injury with increasing creatinine while in the intensive care unit (icu).Diuretics were given as treatment.The patient also had new st-elevation in lead ii and atrial fibrillation noted on ecg.On (b)(6) 2022, a long-term electrocardiogram (ecg) noted extra systoles and intermittent av block ii.On (b)(6) 2022, a pacemaker was implanted to resolve this event.The patient was reported to be in stable condition.No additional information was provided.
Additional Manufacturer Narrative
An event of of drop in hemoglobin, kidney injury, atrial fibrillation, st-elevation in lead ii, extra systoles and intermittent av block ii were 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: 14073915
• Report Number: 2135147-2022-00150
• Device Sequence Number: 2646815
• Product Code: LWQ
• UDI-Device Identifier: 05414734006316
• UDI-Public: 05414734006316
• 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: 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): 06/02/2022

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: 25CAVGJ-514 00
• Device Catalogue Number: 25CAVGJ-514 00
• Device Lot Number: 8237332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2021
• 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; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 104 KG