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

Model Number 25AGFN-756

Device Problems Perivalvular Leak (1457); Biocompatibility (2886)

Patient Problem Endocarditis (1834)

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On an unknown date an abbott mechanical heart valve was implanted.On (b)(6) 2020, the valve was explanted for infective endocarditis of aortic valve prosthesis with a root abscess leading to a paravalvular leak.Patient status is unknown.Additional information was requested but has not be obtained at this time.

Manufacturer Narrative

Additional information: d10 h3, h6.Explant was reported due to infective endocarditis and endocarditis of the valve prosthesis.The investigation found that the mechanical leaflets opened and closed completely and easily.There was minimal pannus formation on the sewing cuff.In addition to the valve, separate fragments of myocardium were also received, which had areas of necrosis.No inflammation or significant areas of calcification were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported event could not be conclusively determined.

• 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: 9716325
• MDR Text Key: 179612012
• Report Number: 2648612-2020-00012
• 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: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2013
• Device Model Number: 25AGFN-756
• Device Catalogue Number: 25AGFN-756
• Device Lot Number: 2717659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: 04/24/2020
• Supplement Dates FDA Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention