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

Model Number 29AGN-751

Device Problems Perivalvular Leak (1457); Off-Label Use (1494)

Patient Problems Hemolysis (1886); Pneumonia (2011); Stenosis (2263); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

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, "reoperation for mitral paravalvular leak 9 years after the mitral valve replacement", was reviewed.It was reported that a (b)(6) male patient was implanted with a 29 mm sjm regent heart valve in the mitral position 9 years ago due to infectious endocarditis.Coronary artery bypass grafting (cabg) was performed concomitantly.A few years later from the initial implant surgery, paravalvular leakage (pvl) started to be confirmed.However, the degree of leakage was subtle at that time so the patient was closely monitored in outpatient clinic.A few more years later, the patient was hospitalized due to pneumonia and congestive heart failure (chf).After discharge, the patient continued to be treated by medication though recurrence and deterioration of chf was confirmed.The patient was hospitalized again for detail examination.Coronary (graft vessel: lita to lad) was patent though, #4pd was found 90% stenosis.Blood test was t - bilirubin 2.2 mg/dl, hemaglobin 10.4 g/dl and b-type natriuretic peptide (bnp) 765 pg/ml.Pvl was confirmed exacerbated by transthoracic echocardiography (tte) so transesophageal echocardiography( tee) was performed.The area which the regent valve was seated had dehisced from anterior leaflet to lateral side beyond left atrial appendage (laa) and hypermobility of valve seated area was confirmed.Regurgitation flow was confirmed to be circled from anterior side of the left atrium toward septum.The degree of regurgitation was diagnosed as severe.Hemolysis was also confirmed in addition to chf.Based on the observation result above, a redo surgery was scheduled as semi-emergent manner.A redo mitral valve replacement was performed and the 29 mm regent valve was explanted and 27 mm non-abbott valve was implanted instead.Tricuspid valvuloplasty (28 mm competitor's annuloplasty ring), laa closure and cabg (svg to 4pd) were also performed concomitantly.According to intraoperative findings, the regent valve had dehisced two-third circumferentially from anterior side which was as central part toward 8 o'clock to 4 o'clock.The tissue attached to the valve had been fragile though, possible prosthetic valve infection was being denied.No additional information.

Manufacturer Narrative

An event of paravalvular leakage, regurgitation and hemolysis were reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note that per the instruction for use, artmt100122074 revision a , "the sjm regent¿ mechanical heart valve is a bileaflet valve, designed for supra-annular implantation in the aortic position.".

• 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: 12333872
• MDR Text Key: 266978395
• Report Number: 2648612-2021-00087
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 85