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

Model Number	25VAVGJ-515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Dyspnea (1816); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Pleural Effusion (2010); Tachycardia (2095); Electrolyte Imbalance (2196)
Date of Event	03/07/2023
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), (b)(6).It was reported that on (b)(6) 2023, a 25 mm sjm masters series valsalva aortic valved graft was successfully implanted.Heparin was administered during the procedure.On the same day, the patient had bleeding that required a red blood cell, platelet, and plasma transfusion.The physician noted that every single needle hole was bleeding despite the protamine administration.Therefore, pre-emptive modified cabrol patch was created using bovine pericardium.The patch was sutured along the medial aspect of the pa, distal ascending aorta, svc, upper aspect of the right atria and right ventricle using running 4-0 stitch.Once this patching was completed, no more significant bleeding was seen.The patient also had decreased urinary output requiring lactate ringers on (b)(6)2023 and (b)(6) 2023.On (b)(6) 2023, an x-ray was performed and showed that the patient was having a left pleural effusion.The patient also had hypovolemia which required a packed red blood cell transfusion.On (b)(6) 2023, the patient had atrial fibrillation with rapid ventricular response and was treated with amiodarone and metoprolol.On (b)(6) 2023, electrocardiogram (ecg) showed continued issues trying to manage post-op atrial tachycardia.The patient's inr was slightly serotherapeutic at 3.8.When evaluated at the bedside the patient was short of breath at rest, tachycardia, no chest pain other than the incision site, and states they felt palpitations.Amiodarone and metoprolol medications were adjusted.On (b)(6) 2023, the patient underwent cardioversion to normal sinus rhythm.Later that evening the patient's rhythm transitioned to junctional followed by atrial fibrillation then to atrial tachycardia.Amiodarone intravenously was given for 24 hours and a 2nd cardioversion was completed.On (b)(6) 2023 the patient converted to sinus rhythm, then later fluctuated between junctional and atrial tachycardia but asymptomatic.The patient was discharged to home with an inr of 2.4.Due to the above events the patient required prolonged hospitalization.No additional information was reported.
Additional Manufacturer Narrative
An event of bleeding, decreased urinary output, left pleural effusion, hypovolemia, atrial fibrillation and post-op atrial tachycardia was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and that the product met all specifications.Information from the field indicated that heparin was administered during the procedure and the patient's inr at the time of discharge was 2.4.The field also indicated that the physician did not believe that the reported event was as a result of the device's performance during the procedure.Based on the information received the cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
N/a.

• 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: 16668744
• Report Number: 2135147-2023-01457
• Device Sequence Number: 20314515
• Product Code: LWQ
• UDI-Device Identifier: 05414734009492
• UDI-Public: 05414734009492
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023

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: 03/31/2025
• Device Model Number: 25VAVGJ-515
• Device Catalogue Number: 25VAVGJ-515
• Device Lot Number: 31337144
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2023
• 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: 44 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: White