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 Anemia (1706); Pleural Effusion (2010); Pericardial Effusion (3271)

Event Date 03/17/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Clinical information: crd_992 - valved grafts pas, patient site id: (b)(6), (b)(4).It was reported that on (b)(6) 2023, a 25mm sjm masters series valsalva aortic valved graft was implanted.On (b)(6) 2023, an x-ray excluded fluid components in the pleural cavity, and 1 unit of red blood cells was transfused due to low hemoglobin.On (b)(6) 2023, fluid was seen in the left pleural cavity on ultrasound.On (b)(6) 2023, fluid was observed in the pericardial sac on transthoracic echocardiogram (tte), and 1 unit of red blood cells was transfused due to low hemoglobin.On (b)(6) 2023, fluid visualized in the pericardial sac up to 13mm at the right ventricle and right atrium.The pericardial effusion and low hemoglobin were both related to the procedure itself.There was no malfunction of the device.The patient's hospitalization was prolonged.The patient was later discharged.

Event Description

Clinical information: (b)(6) - valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 25mm sjm masters series valsalva aortic valved graft was implanted.The patient received a blood and platelet transfusion.On (b)(6) 2023, the patient received a blood transfusion.On (b)(6) 2023, an x-ray excluded fluid components in the pleural cavity, and 1 unit of red blood cells was transfused due to low hemoglobin.On (b)(6) 2023, fluid was seen in the left pleural cavity on ultrasound.On (b)(6) 2023, fluid was observed in the pericardial sac on transthoracic echocardiogram (tte), and 1 unit of red blood cells was transfused due to low hemoglobin.On (b)(6) 2023, fluid visualized in the pericardial sac up to 13mm at the right ventricle and right atrium.The pericardial effusion and low hemoglobin were both related to the procedure itself.There was no malfunction of the device.The patient's hospitalization was prolonged.The patient was later discharged.

Manufacturer Narrative

An event of pericardial effusion, low hemoglobin and prolonged hospitalization 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 the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.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: 16742965
• MDR Text Key: 313343062
• Report Number: 2135147-2023-01649
• 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: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Model Number: 25VAVGJ-515
• Device Catalogue Number: 25VAVGJ-515
• Device Lot Number: 8274547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: White