MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. STANDARD 23 MM ST. JUDE MEDICAL AORTIC VALVE; HEART-VALVE, MECHANICAL

Model Number 23A-101

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombus (2101)

Event Date 12/09/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a 23mm mechanical valve (standard) was implanted in the aortic position in a patient with complex congenital heart disease.The patient had undergone multiple previous operations including a konno procedure that had now calcified.After discharge, the patient was not compliant with prescribed anticoagulation therapy and at the time of readmission, the mechanical valve had evidence that it was now thrombosed and required intervention.The patient was placed on tandem heart lvad to support stable hemodynamic status and treated until (b)(6) 2018 when the patient was brought to the operating room.At surgery, tissue and debris were removed from the valve; however the valve remained implanted.Post-operatively, the patient is reported to be stable.

Manufacturer Narrative

An event of thrombus was reported in a patient with known non-compliance with the prescribed anticoagulation regiment.As the device remains implanted, no device analysis is available.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident is related to the thrombus formation on the valve in a non-compliant patient.

• Brand Name: STANDARD 23 MM ST. JUDE MEDICAL AORTIC VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 8224596
• MDR Text Key: 132333828
• Report Number: 2648612-2019-00001
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 23A-101
• Device Catalogue Number: 23A-101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR