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

Model Number 25VAVGJ-515

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Pericardial Effusion (3271)

Event Date 05/10/2023

Event Type  Injury  

Event Description

Crd_992 - valved grafts pas, pl5012 - 1208 (r754694501, r754887801, r754887801).It was reported that on (b)(6)2023, a 25mm masters series¿ hp valved graft was implanted in a patient.On (b)(6)2023, echocardiography showed 6 mm of fluid in the pericardial sac.On (b)(6)2023, the patient had atrial fibrillation and was treated with cordarone intravenously.On (b)(6)2023, the patient had symmetrically creaks below the angles of the shoulder blades.The cause is unknown, and surgical intervention was performed.On (b)(6)20023, repeated echocardiography showed 8 mm of fluid in the pericardial sac, with no echocardiographic features of tamponade.Fluid in the left pleural cavity up to 50 mm.No treatment was provided.(b)(6)2023, x-ray did not show obvious features of pneumothorax.Shadowing of the lower, left lung field fluid in the left pleural cavity with changes of atelectasis/atelectasis-inflammatory nature.A transthoracic echocardiogram (tte) showed fluid in the pericardial sac up to 10 mm at the posterior wall, left ventricle side and right atrial roof.Fluid up to 53mm in the left pleura.On (b)(6) 2023, surgical intervention was performed to removed the fluid.On (b)(6)2023, the patient had red blood cells transfused.The patient was stable.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

An event of atrial fibrillation, pneumothorax, pericardial effusion and the patient having symmetrically creaks below the angles of the shoulder blades was 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 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
• Type of Device: 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: 17079181
• MDR Text Key: 317029794
• Report Number: 2135147-2023-02485
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25VAVGJ-515
• Device Catalogue Number: 25VAVGJ-515
• Device Lot Number: 8902174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Race: White