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

Model Number 27VAVGJ-515

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

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Pericardial Effusion (3271); Thrombosis/Thrombus (4440)

Event Date 02/19/2023

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).It was reported that on (b)(6) 2023, a 27mm sjm masters series valsalva aortic valved graft was implanted.No concomitant cardiac procedures were performed during the same surgery.There were no intraprocedural adverse events reported.On (b)(6) 2023, prior to discharge, a transthoracic echocardiogram (tte) was performed which revealed the presence of fluid/pericardial effusion.On (b)(6) 2023, the patient experienced a cardiac tamponade of the pericardial sac, and another thoracotomy was performed.After the incision, a large amount of purulent content was evacuated.In the pericardial sac, there were clots noted under the sternum.In the region of the lower and lateral walls of the heart, there was 1250ml of dark blood.Patient developed anemia, therefore one unit of red blood cells was transfused.The tamponade was decompressed.Prolonged hospitalization was reported due to treatment.The patient was prescribed prophylactic antibiotic therapy.The cause of the purulent content and blood clots was believed to be the result of the cardiac tamponade and the presence of blood in the pleural cavities.The pericardial effusion and cardiac tamponade were believed to be related to the procedure and not related to the device.No additional information was provided.

Event Description

N/a.

Manufacturer Narrative

An event of presence of fluid/pericardial effusion, cardiac tamponade of pericardial sac, clots under the sternum and anemia was reported.It was also reported that there were after the incision, a large amount of purulent content was evacuated.A returned device assessment could not be performed as the device remains implants 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 Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16584304
• MDR Text Key: 311697100
• Report Number: 2135147-2023-01278
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734009515
• UDI-Public: 05414734009515
• 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: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 27VAVGJ-515
• Device Catalogue Number: 27VAVGJ-515
• Device Lot Number: 8491487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Race: White