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

Model Number	21VAVGJ-515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	04/18/2023
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
Crd_992 - valved grafts pas.Eu0336 - 702 (r751347001, r751348701) it was reported that on (b)(6) 2023, a 21mm masters series¿ hp valved graft with gelweave valsalva technology (vavgj) was implanted in a patient.On (b)(6) 2023, the patient presented with hyperthermia due to infection.Medication was administered/adjusted.On (b)(6) 2023, transthoracic echocardiogram showed pericardium, localized pericardial effusion opposite the latero- and postero-ventricle wall, probably partitioned at 17 mm postero- ventricle, 17 mm latero-left ventricle, no repercussions on the cardiac chamber.A computerized tomography (ct) scan on (b)(6)2023, showed the appearance of an abundant pericardial effusion, measuring up to 27 mm in thickness opposite the lateral wall of the left ventricle.The pericardial effusion lead to cardiac tamponade medication was administered/adjusted.The patient was also treated with enoxaparin an anti-thrombotic regimen.On (b)(6) 2023, the patient presented for evacuation of the pericardial effusion by marfan with placement of 2 drains (latero lv and infero rv) and a thoracic drain.On (b)(6) 2023, tte and ct was performed and showed persistent pericardial effusion.The patient is stable.
Additional Manufacturer Narrative
An event of pericardial effusion lead to cardiac tamponade was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Field noted that event was not caused by a abbott device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 16942902
• Report Number: 2135147-2023-02139
• Device Sequence Number: 17047464
• Product Code: LWQ
• UDI-Device Identifier: 05414734009478
• UDI-Public: 05414734009478
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/23/2023

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: 09/30/2025
• Device Model Number: 21VAVGJ-515
• Device Catalogue Number: 21VAVGJ-515
• Device Lot Number: 31235429
• 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: 04/21/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2022
• 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: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 65 KG