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

Model Number 17AGFN-756

Device Problem Obstruction of Flow (2423)

Patient Problems Aortic Insufficiency (1715); Aortic Valve Stenosis (1717)

Event Date 10/15/2018

Event Type  Injury  

Event Description

On (b)(6) 2010, a 17mm regent mechanical heart valve was implanted in the aortic position and a concomitant mvr was performed with a 25mm carbomedics mechanical heart valve implanted.The patient had suffered from rheumatic combined valvular disease, aortic regurgitation, msr, atrial fibrillation, tricuspid regurgitation and a tricuspid annuloplasty was performed.Throughout 2018, the patient presented with high gradient (peak gradient 117mmhg and mean gradient 63mmhg) and worsening symptoms of congestive heart failure, aortic stenosis and tricuspid regurgitation.On (b)(6) 2018, the 17mm regent valve was explanted and a bentall procedure was performed with concomitant tricuspid annuloplasty.During the procedure, moderate pannus proliferation was observed under the sub-valvular tissue that did not obstruct the mechanical valve leaflet.The patient is reported to be stable.

Manufacturer Narrative

An event of stenosis and high gradient was reported.The reported pannus was confirmed.Morphological and histopathological examination revealed partially detached fibrous pannus ingrowth.Due to the state of the pannus and sewing cuff of the returned valve, it was not possible to definitively determine the location of the pannus, or if the pannus interfered with the valve inflow, prior to explant.The mechanical leaflets opened and closed completely and were fully mobile.No inflammation or significant calcifications were found in the sewing cuff or pannus.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown; however, information from the field indicated that the patient had a medical history that included rheumatic combined valvular disease, msr and atrial fibrillation.The patient had comorbidities including congestive heart failure and tricuspid regurgitation.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• 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: 8039987
• MDR Text Key: 126215533
• Report Number: 2648612-2018-00091
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• 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: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 17AGFN-756
• Device Catalogue Number: 17AGFN-756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention