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

Model Number 21VAVGJ-515

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

Patient Problems Unspecified Infection (1930); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 04/18/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

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.

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
• 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: 16942902
• MDR Text Key: 315355975
• Report Number: 2135147-2023-02139
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734009478
• UDI-Public: 05414734009478
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2022
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 65 KG