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

Model Number 29AGN-751

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Arrhythmia (1721); Obstruction/Occlusion (2422); Heart Failure/Congestive Heart Failure (4446)

Event Type  Injury  

Manufacturer Narrative

Along with investigation results will be provided in the final report.

Event Description

The article, "iatrogenic left circumflex coronary occlusion following mitral valve replacement surgery", was reviewed.This research article reported that in august of 2018, a (b)(6) year old women with a history of severe rheumatismal mitral stenosis and balloon mitral valvulotomy in 2010 and 2012, respectively, was admitted to the tehran heart center with a complaint of dyspnea on exertion.Patient had atrial fibrillation rhythm.Pre-operative coronary angiography showed an intact left circumflex coronary artery (lcx).Three days after admission the patient underwent mitral valve replacement (mvr) through mid-sternotomy.The anterior leaflet of the atrium was resected and the valve was replaced with a regent st jude mechanical valve (#29).Six hours post-surgery, the patient developed a sustained monomorphic ventricular tachycardia, which was instantly cardioverted.Intravenous amiodarone was started with bolus dose of 150mg and 1mg/min infusion.Then again one hour after the patient was extubated, the monomorphic ventricular tachycardia reoccurred, which was successfully cardioverted to atrial fibrillation rhythm.Urgent transthoracic echocardiography showed significant hypokinesia in the lcx territory.An angiography revealed occlusion in the lcx at the mid-part.It was noted that it was probably due to the compressive effect of the prosthetic valve on the artery.Percutaneous coronary intervention (pci) was performed to place a stent, which was unsuccessful.The patient was placed on conservative medication, while receiving inotrope agents and anti-ischemic therapy, the patient maintained on the balloon pump for three days due to lv hypokinesia and low lvef.Pt was discharged 3 days after removal of the pump in stable condition and with improved cardiac function.Follow up echocardiography on (b)(6) 2019, a normal functioning prosthetic mitral valve with good bi-leaflet motion, acceptable gradient and minimal paravalvular leak from the anterior side of the swing ring.The article concluded that although iatrogenic damage to the lcx caused by the excision and removal of the valve in mvr surgery rate may be low, the prevention of such complication requires ct angiography (ca) in all patients undergoing valve surgery with a view to verify location of lcx.The primary author of this article is negin yavari, research department, tehran heart center, tehran university of medical sciences, tehran, iran.The correspondence author is seyed hossein ahmadi taft, department of cardiac surgery, tehran heart center, tehran university of medical sciences, tehran, iran with the corresponding email: ahmadita@sina.Tums.Ac.Ir.

Manufacturer Narrative

As reported in a research article, in august of 2018 a patient had a mitral valve replacement with a sjm regent heart valve.Events of monomorphic ventricular tachycardia, atrial fibrillation, hypokinesia in the left circumflex coronary artery territory, occlusion of the left circumflex coronary artery, left ventricle hypokinesia, and minimal paravalvular leak 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 REGENT 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
• MDR Report Key: 11440966
• MDR Text Key: 239167941
• Report Number: 2648612-2021-00018
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 04/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 29AGN-751
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR