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 Atrial Fibrillation (1729); Dyspnea (1816)

Event Date 04/14/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on 12 april 2022, a 21mm sjm masters series valsalva aortic valved graft was successfully implanted.A coronary artery bypass graft (cabg), a mitral valve repair, and a tricuspid valve repair were also performed during the same surgery.There were no intraprocedural adverse events noted.On 13 april 2022, laboratory analysis showed lactatemia, and patient's lactate was 61mg/dl.On 14 april 2022, the patient experienced hemodynamically relevant bradycardic atrial fibrillation on electrocardiogram (ekg).The patient then had intermittent tachycardic atrial fibrillation.Cardioversion was performed twice without success.On 24 april 2022, the patient was noted to have bilateral pleural effusion leading to tachypnea and dyspnea.A thoracentesis was required, and the patient was temporarily transferred back to the intensive care unit (icu).The antiarrhythmic amiodarone was administered.No additional information was provided.

Manufacturer Narrative

An event of atrial fibrillation and pleural effusion two days after the procedure was reported.Information from the field indicated it was thought that the events were due to the procedure.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: 14414764
• MDR Text Key: 291821814
• Report Number: 2135147-2022-00284
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734009478
• UDI-Public: 05414734009478
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 21VAVGJ-515
• Device Catalogue Number: 21VAVGJ-515
• Device Lot Number: 6586803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2018
• 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; Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian