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 Hemorrhage/Bleeding (1888); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Date 09/30/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

The article, "maternal and fetal outcomes of pregnancy in women with mechanical heart valves prostheses - a single-center experience", was reviewed.This research article is a retrospective single center experience to assess the pregnancy course and the incidence of maternal complications regarding different anticoagulation regimens in women with mechanical heart valves (mhv).On x (cryolife), sjm mechanical valve (abbott), bjork-shiley and sorin bicarbon valves were associated with the study.The article concluded that there is no safe anticoagulation regimen in pregnant women with mechanical heart valves.The impressive rate of complications in this high-risk group advocates for the centralization of their care.The primary and correspondence author of the article is agnieszka bartczak-rutkowska, md, phd, 1st department of cardiology, poznan university of medical sciences, dluga 1/2, 61¿848 poznan, poland with the corresponding email: aga.Bartczak@gmail.Com.

Manufacturer Narrative

As reported in a research article, 19 pregnant women were implanted with a mechanical heart valve (mhv) between 2003-2018; 2 patients were implanted with an aortic sjm mechanical heart valve, 7 patients were implanted with a mitral sjm mechanical heart valve and 1 patient had a tricuspid sjm mechanical heart valve implanted.Events of mechanical valve thrombosis, urgent valve surgery, ischemic stroke, postpartum hemorrhage that required obstetrical intervention and blood transfusion 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.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12858244
• MDR Text Key: 282631079
• Report Number: 2648612-2021-00104
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• 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: 12/14/2021
• 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): Other; Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female