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

Model Number CVD0040

Device Problems Backflow (1064); Perivalvular Leak (1457)

Patient Problems Mitral Insufficiency (1963); Hemolytic Anemia (2279); Cardiac Perforation (2513)

Event Type  Injury  

Manufacturer Narrative

In an article, multiple events necessitating valve replacement due to paravalvular leakage and regurgitation and no fault effects of cardiac perforation, anemia and hypertension were reported.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that a study was conducted where medical records from january 2008 to december 2018 for 25 mitral valve patients, including 4 abbott mechanical heart valves, requiring reoperation were collected.The majority of mitral valve dysfunction were paravalvular leaks, open - closure dysfunction, and perforation.Two patients died of cardiac causes before reoperation (one died in the hospital due to malignant arrhythmia, the other self-discharged due to financial issues and died of heart failure after 22 days) and an unknown number of patients required blood transfusions.Post-operative complications included cardiac dysfunction, arrhythmia, sepsis, pulmonary infection, gastrointestinal bleeding, cerebral hemorrhage, chronic renal dysfunction, and surgical hemorrhage.Five (5) patients died after reoperation from cardiac dysfunction, septic shock, and self-discharge.Manufacturer report number: 2648612-2020-00030.

• Brand Name: SJM MECHANICAL HEART 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 ; RQ 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; RQ 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9878406
• MDR Text Key: 189709019
• Report Number: 2648612-2020-00029
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CVD0040
• Device Catalogue Number: CVD0040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2020
• 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): Hospitalization; Life Threatening; Other; Required Intervention