MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES MECHANICAL HEART VALVE; ROTATABLE HEART VALVE

Model Number 23AJ-501

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

Patient Problems Congenital Defect/Deformity (1782); Thrombus (2101); Cardiac Tamponade (2226)

Event Date 05/06/2011

Event Type  Injury  

Event Description

The information in a literature article indicated the pt underwent aortic valve replacement with this 23 mm sjm masters series valve due to persistent left atrioventricular regurgitation.Inr was maintained and approximately one month postoperatively, the pt presented with dyspnea and the valve was determined to be thrombosed.Thrombolytic therapy with urokinase was performed.One month after the emergency thrombectomy, the pt presented with an elevated heart rate and tachypnea.The valve was found to be thrombosed again.The valve was explanted and a smaller 21 mm sjm masters series valve (medwatch report #2648612-2014-00026) was implanted.Ten days following the re-do valve replacement, the pt presented again with dyspnea and intensified peripheral coldness.Thrombolytic therapy was unsuccessful and circulation was unstable.The 21 mm valve was explanted and replaced with a 22 mm valve from another manufacturer.According to the literature article, the hypereosinophilia was strongly suspected to be the cause of the repeated valve thrombosis.Antibiotics were suspected to be the cause of the hypereosinophilia.Therefore, the administration of antibiotics was stopped, the eosinophil count was gradually normalized, and the pt was discharged in good condition.It was reported the physician alleged this event was not caused by the valves.Kido t., et al, "repeated obstructive prosthetic valve thrombosis suspected to be associated with hypereosinophilic syndrome in complete atrioventricular septal defect, " pediatric cardiology and cardiac surgery, vol.30 no.2 (200-204).

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported thrombus was suspected to be caused by hypereosinophilia.The physician did not allege the event was caused by the device.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Type of Device: ROTATABLE HEART VALVE
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; caguas PR
• Manufacturer Contact: denise johnson, rn ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 3883748
• MDR Text Key: 4543199
• Report Number: 2648612-2014-00025
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2015
• Device Model Number: 23AJ-501
• Device Catalogue Number: 23AJ-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2010
• 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: 4 YR
• Patient Weight: 13