MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MECHANICAL HEART VALVE (UNKNOWN); HEART-VALVE, MECHANICAL

Model Number CVD0039

Device Problems Gradient Increase (1270); Biocompatibility (2886)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.

Event Description

The patient presented with a history of rheumatic mitral valve disease and was treated with a st.Jude mechanical 25 mm bileaflet prosthetic valve.18 months later patient presented with a 2-week history of worsening dyspnea on exertion and orthopnea.Patient was started on a heparin drip for possible thrombotic mitral valve, then underwent repeat tee the next day, which showed no clear thrombus or mass on the prosthetic mitral valve, but persistent restricted prosthetic motion with elevated mean gradient at 27 mm hg.The physician then elected to proceed with fibrinolytic therapy for suspected prosthetic mitral valve thrombosis and started the (b)(6) clinic protocol of alteplase 20 mg bolus followed by 30 mg infusion drip over 3 hours.This improved the mean gradient.The same protocol was repeated to further improve the mean gradient and repaired the movement of the leaflets.6-month follow-up tte showed properly functioning mitral valve prosthetic with normal pressure gradient across the prosthetic article title: successful fibrinolytic therapy in a challenging obstructive prosthetic mitral valve thrombosis.

Manufacturer Narrative

As reported in a research article, a patient had worsening dyspnea on exertion and orthopnea and the leaflets of the valve were noted to be obstructed by a suspected thrombus, with an increase in gradient also noted.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM MECHANICAL HEART VALVE (UNKNOWN)
• 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: 10244340
• MDR Text Key: 197920110
• Report Number: 2648612-2020-00078
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CVD0039
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR