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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Renal Failure (2041); Sepsis (2067); Thrombosis/Thrombus (4440); Heart Block (4444)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, 29 patients underwent mitral valve replacement from may 2002 to december 2020; st.Jude medical mitral valve, carbomedics, st.Jude medical aortic valve, on-x, other tissue valves were associated with the study.A total of 21 patients were implanted with a st.Jude medical valve.Events of heart block, permanent pacemaker implantation, bleeding, sepsis, thrombosis, stroke, hemothorax, renal failure, respiratory failure, pulmonary hypertension, one patient required extracorporeal membrane oxygenation (ecmo) and re-do mitral valve replacements were reported.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.

Event Description

Related manufacturing reference number: 2648612-2021-00088.The article, "mitral valve replacement in infants and younger children", was reviewed.This research article is a retrospective single center experience to evaluate our experience with mitral valve replacement in infants and young children less than 5 years old and identify factors affecting the outcomes.St.Jude medical mitral valve, carbomedics, st.Jude medical aortic valve, on-x, other tissue valves were associated with the study.The article concluded that mitral valve replacement in children is associated with low morbidity and mortality.The risk of reoperation could be affected by the valve size and position rather than the age.The primary and correspondence author of the article is ahmed f.Elmahrouk, division of cardiac surgery, cardiovascular department, king faisal specialist hospital and research center, mbc j-16, p.O.Box: 40047, jeddah 21499, saudi arabia with the corresponding email: ael-mahrouk@kfshrc.Edu.Sa.

• 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 ; * 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12409447
• MDR Text Key: 270146187
• Report Number: 2648612-2021-00089
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2021
• 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): Life Threatening; Required Intervention
• Patient Age: 19 MO
• Patient Weight: 9