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

Model Number CVD0039

Device Problem Unstable (1667)

Patient Problems Mitral Insufficiency (1963); Hemolytic Anemia (2279)

Event Type  Injury  

Manufacturer Narrative

Gtin/manufacturer unknown as lot/serial numbers were not available.The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

According to the article "a case of re-do mitral valve replacement due to hemolysis by mitral valve dysfunction" (02-3-1), the patient had avr in 2006 due to aortic stenosis with high gradient and a valve (model, manufacturer unknown) was implanted.The patient had severe mitral calcification since then and was followed-up.In (b)(6) 2014, this 23mm sjm mechanical valve was implanted.A tee performed post-procedure revealed no regurgitation.In (b)(6) 2014, anemia and high ldh were observed and the patient was admitted to the hospital and diagnosed with hemolytic anemia secondary to mitral valve dysfunction.A re-do mitral valve replacement procedure was performed.Intraoperatively, 3d images confirmed one leaflet was unstable and this 23mm valve was explanted.The physician suspected that some structural impedance affected the ventricular side.A 21mm sjm regent valve (for aortic use) was implanted in the mitral position with reversal position.No regurgitation was observed on tee after taking the patient off bypass.

• Brand Name: SJM MECHANICAL HEART VALVE (UNKNOWN)
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5231262
• MDR Text Key: 31452848
• Report Number: 3007113487-2015-00049
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CVD0039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 74 YR