MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MECHANICAL HEART V ALVE W/TEFLON CUFF; STANDARD HEART VALVE

Model Number 29MT-103

Device Problems Occlusion Within Device (1423); Reflux within Device (1522)

Patient Problems Dyspnea (1816); Mitral Valve Stenosis (1965); Pulmonary Edema (2020)

Event Date 06/20/2013

Event Type  Injury  

Event Description

The information provided to sjm from a literature article titled, "the detailed observation of valve dysfunction of sudden dyspnea 10 years after mitral valve replacement using three-dimensional tee echocardiography," indicted approximately 10 years postoperatively, the patient presented to the hospital with orthopnea and obvious lung congestion.However, no left ventricular hypertrophy was observed and the ejection fraction was favorable on transthoracic echocardiography.One leaflet was immobile and color doppler showed high turbulence.Prosthetic valve stenosis was indicated.Inr was reduced to 1.28.Continuous heparin treatment with drip infusion and emulgent treatment were performed and the symptoms improved.Transesophageal echocardiography revealed one leaflet was immobile and 3d echo revealed there was thrombus-like mass on the leaflet which impeded the leaflet's mobility.Warfarin was increased.Transesophageal echocardiography revealed the leaflet's mobility improved.The patient hemodynamic status was stable and the valve remains implanted.It was reported the physician did not allege the event was caused by the device.

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, 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 immobile leaflet resulting in stenosis remains unknown.

• Brand Name: SJM MECHANICAL HEART V ALVE W/TEFLON CUFF
• Type of Device: STANDARD 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: 3940194
• MDR Text Key: 4577696
• Report Number: 2648612-2014-00030
• 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,Company Representative
• Type of Report: Initial
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2008
• Device Model Number: 29MT-103
• Device Catalogue Number: 29MT-103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2003
• 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: 63 YR