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

Model Number 19AGFN-756

Device Problem Perivalvular Leak (1457)

Patient Problems Aortic Regurgitation (1716); Endocarditis (1834)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

An event of perivalvular leakage was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined. information from the field indicated that the perivalvular leakage was due to disruption of the patient's native aortic annulus caused by infective endocarditis.The physician indicated "no anomalies such as adhesions of the leaflets or within the pivot guards.".

Event Description

On (b)(6) 2007, an aortic valve replacement (avr) was performed and this 19mm regent mechanical heart valve was implanted in the supra annular position using non-everting mattress sutures with pledgets.Reportedly, no significant calcification was observed at the patient's native aortic annulus and annular enlargement procedure was not required.On an unknown date, aortic regurgitation (ar) was confirmed.On (b)(6) 2018, re-do avr was performed for the treatment of perivalvular leakage (pvl).Per surgeon, reported pvl was due to disruption of the patient's native aortic annulus caused by infective endocarditis.The 19mm regent heart valve was explanted and observed with no anomalies such as adhesion of the leaflets or within the pivot guards.Per user, tissue removal and patch annuloplasty were not required for the infected site and a 19mm trifecta gt valve was implanted.The procedure was completed uneventfully and the patient was reported to be in stable condition postoperatively.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8233558
• MDR Text Key: 132603430
• Report Number: 2648612-2019-00005
• Device Sequence Number: 1
• Product Code: LWQ
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2012
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2007
• 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): Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 42