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

Model Number 23AGFN-756

Device Problem Backflow (1064)

Patient Problem Aortic Regurgitation (1716)

Event Date 09/17/2019

Event Type  Injury  

Event Description

On (b)(6) 2018, a mechanical mitral valve replacement and aortic valve replacement was performed implanted a 23 mm regent valve in the aortic position.In (b)(6) 2019, an ultrasound displayed moderate to severe regurgitation of the regent aortic valve.On (b)(6) 2019, the aortic valve was replaced successfully.The patient remained stable.

Manufacturer Narrative

An event of regurgitation was reported.The investigation found that the mechanical leaflets opened and closed completely.There was fibrous pannus present on the sewing cuff.Fugnal hyphae was present on the surface of the sewing cuff, and was interpreted as a contaminant.No inflammation or significant calcifications 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 regurgitation could not be conclusively determined.

Event Description

On (b)(6) 2018, a mechanical mitral valve replacement and aortic valve replacement was performed.In (b)(6) 2019, an ultrasound displayed moderate to severe regurgitation of the regent aortic valve.On (b)(6) 2019, the aortic valve was replaced successfully.The patient remained stable.The patient's inr was 1.8-2.5.

• 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: 9180632
• MDR Text Key: 161991484
• Report Number: 2648612-2019-00083
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: 05414734006095
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2022
• Device Model Number: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: 6056531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention