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 Atrial Fibrillation (1729); Hemorrhage/Bleeding (1888); Thrombosis (2100); Complete Heart Block (2627); Pericardial Effusion (3271)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, 75 pediatric patients were implanted with mechanical heart valves between 1995 and 2019.74 of the mechanical heart valves implanted were st.Jude medical products.1 patient had an event of bleeding, 5 patients had atrioventricular block, 1 patient had mitral valve thrombosis, 2 patients required pericardial drainage, 2 patients required extracorporeal membrane oxygenation support, and 18 patients required another operation for a second mechanical heart valve, with 1 patient requiring a third mechanical heart valve operation.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

The article "mechanical mitral valve replacements in the pediatric population" was reviewed.This research article is a retrospective single center experience to evaluate the range of prosthetic size-to-weight ratio to optimize valve survival in small children.Abbott mechanical heart valves and on-x valves were associated to the study.There is no allegation of malfunction of the abbott device.The article concluded that patients¿ increased prosthesis valve size-to-weight ratio is associated with increased risk of reoperation and an increase in 1-2 times this ratio would suggest longer reintervention-free survival in small children weighing =35kg.The primary author of the article is christopher ibarra, md of division of congenital heart surgery, texas children¿s hospital.The correspondence author is michiaki imamura, md of division of congenital heart surgery, texas children¿s hospital with the corresponding email: mximamur@texaschildrens.Org.

• 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: 10814769
• MDR Text Key: 215482284
• Report Number: 2648612-2020-00117
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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: 10/24/2020
• 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): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 13