MAUDE Adverse Event Report: ABBOTT MEDICAL REGENT HEART VALVE; HEART-VALVE, MECHANICAL

Catalog Number 25AGN-751

Device Problem Off-Label Use (1494)

Patient Problem Hypoxia (1918)

Event Date 10/05/2023

Event Type  Injury  

Manufacturer Narrative

As reported through a literature article, "redo mitral valve replacement in an adult atrioventricular septal defect heart with severe pulmonary hypertension: a case study", a 37-year-old woman who had undergone patch closure for a partial avsd and mitral valve replacement with a rather large bioprosthesis at the juxta-annular position for mitral regurgitation 12 years earlier was referred to our institute because of severe pulmonary hypertension (ph).Echocardiography revealed calcification resulting in severe stenosis of the bioprosthesis and protrusion of its stent post into the left ventricular outflow tract; therefore, redo mitral valve replacement at the supra-annular position was performed using a mechanical valve.Combined group i and ii ph gradually improved with meticulous postoperative medical management.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per regent mechanical heart valve, instructions for use, " indications: the sjm regent¿ mechanical heart valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic valve.This device may also be used to replace a previously implanted aortic prosthetic heart valve." this is considered as an off-label use of the device.However, it was unable to determine if the off-label use contributed to the reported incident.Therefore, a letter will not be provided to address the deviation from the ifu.

Event Description

The article, ¿redo mitral valve replacement in an adult atrioventricular septal defect heart with severe pulmonary hypertension: a case study¿, was reviewed.The article presented a case study of a 37-year-old female with severe pulmonary hypertension with prior cardiac surgery to treat atrioventricular septal defect, prior mitral valve replacement with a 29mm perimount valve (edwards lifesciences) for mitral regurgitation, prior tricuspid suture annuloplasty, and epicardial pacing leads implant procedure for tricuspid regurgitation, and pacemaker implanted for atrioventricular block.It was reported that on an unknown date, the patient presented with dyspnea.It was then reported three years later on an unknown date, the patient was referred to a hospital for severe pulmonary hypertension, heart failure, cardiomegaly, enlarged pulmonary artery, severe bioprosthetic calcification, and left ventricular outflow tract obstruction.A decision was made to perform redo mitral valve replacement with a 25mm sjm regent mechanical valve and tricuspid valve annuloplasty with a 27mm sjm tailor band.It was also reported during a concomitant aortic valve repair procedure, a 17mm sjm regent mechanical valve was chosen for implant.During the aortic valve repair procedure, it was reported the 17mm regent valve could not be seated in the patient¿s small annulus and a decision was made to downsize to a 16mm ats-ap (medtronic) mechanical valve.The patient also had another concomitant procedure to repair atrial septal defect with a bovine pericardial patch.It was reported post-procedure, the patient was discharged with home oxygen therapy for hypoxia that was maintained, bosentan hydrate for 2 months, digoxin for 4 years before replaced with bisoprolol fumarate, and diuretics.The patient status was reported as stable after 6 years of follow up.The article concluded the occurrence of lvoto should be considered in adult patients with avsd, which may be prevented by mitral valve repair.Pulmonary hypertension complicated by left-sided heart disease in an adult with congenital heart disease should be carefully managed with optimal medical therapy in addition to surgical correction.[the primary and corresponding author was hitoshi ogino, department of cardiovascular surgery, tokyo medical university hospital, 6-7-1 nishishinjuku, shinjuku-ku, tokyo 160-0023, japan, with corresponding email: hogino@tokyo-med.Ac.Jp].

• Brand Name: REGENT HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18030427
• MDR Text Key: 326908413
• Report Number: 2135147-2023-04760
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006279
• UDI-Public: 05414734006279
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 25AGN-751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• 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: 37 YR
• Patient Sex: Female