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 Problems Backflow (1064); Obstruction of Flow (2423)

Patient Problems Regurgitation, Valvular (2335); Valvular Insufficiency/ Regurgitation (4449)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2020, the patient underwent aortic valve replacement and a 19mm sjm regent heart valve w/flex cuff was implanted in the patient.However, ultrasound examination before discharge showed that one leaflet was not fully closed and the physician indicated moderate regurgitation.The patient was treated with drug therapy and at present, the patient is in good health with no adverse events.There is no specific sign of thrombosis and the patient was discharged from the hospital with no prolonged hospital stay.The patient has been advised to come to the hospital three months later for examination of valve function.

Manufacturer Narrative

An event of regurgitation was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis; however, 4 videos were received for analysis.Based solely on the aforementioned videos, there did appear to be aortic regurgitation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident 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: 10924647
• MDR Text Key: 218971438
• Report Number: 2648612-2020-00130
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005852
• UDI-Public: 05414734005852
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: 7408504
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1