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

Catalog Number	23VAVGJ-515
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Endocarditis (1834); Fatigue (1849); Pain (1994); Pseudoaneurysm (2605)
Date of Event	06/27/2024
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 successfully implanted in a patient.On (b)(6) 2024, the patient was admitted at the emergency room with complaint of chest pain of the course of 7 days.The patient's chest pain was noted to have worsened in the last two days.A chest computed tomography angiogram was performed and revealed a pseudoaneurysm.An unknown treatment was performed.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that the patient had cervical pain radiating to the right upper limb for 7 days with worsening symptoms 48 hours before being admitted to the hospital.It was also noted that the patient had associated right shoulder weakness and a throbbing sensation in the suprasternal region.The patient was administered zaldiar and arcoxia, without improvement in symptoms.The patient was also administered empiric antibiotics (ceftriaxone and daptomycin).The cause of the patient's pseudoaneurysm is attributed to oligosymptomatic endocarditis, that involves the 23mm sjm masters series valsalva aortic valved graft.A positive culture on the valve itself was confirmed as cutibacterium acnes.On (b)(6) 2024, the decision was made to explant the 23mm sjm masters series valsalva aortic valved graft and replace it was a 21mm sjm masters series valsalva aortic valved graft.There was no allegation of malfunction against the abbott device or procedure.The patient was discharged at the time of report.
Additional Manufacturer Narrative
An event of worsening chest pain and pseudoaneurysm which was attributed to oligosymptomatic endocarditis was reported.Also reported that the patient had cervical pain radiating to the right upper limb for 7 days with worsening symptoms 48 hours before being admitted to the hospital.A more comprehensive assessment, including histopathological examination of the valve could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The reported surgical intervention was due to explant of 23 mm masters series valved graft and replacement with a 21 mm masters series valved graft.The reported unexpected medical intervention was to administer medication.The device history record was also 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 VALSALVA AORTIC VALVES GRAFT
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19842154
• Report Number: 2135147-2024-03647
• Device Sequence Number: 7595003
• Product Code: LWQ
• UDI-Device Identifier: 05414734009522
• UDI-Public: (01)05414734009522(17)241130(10)8498712
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 09/13/2024

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 Expiration Date: 11/30/2024
• Device Catalogue Number: 23VAVGJ-515
• Device Lot Number: 8498712
• 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: 07/01/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 96 KG