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 Obstruction of Flow (2423)

Patient Problems Thrombus (2101); Heart Failure (2206); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.

Event Description

On (b)(6) 2007, a 19mm regent valve was implanted in the aortic position.In (b)(6) 2018, high gradient and stenosis were observed and on (b)(6) 2018, the patient was admitted to the hospital for heart failure.On (b)(6) 2018, a valve replacement surgery was performed and the valve was exchanged for another 19mm regent valve (serial number: (b)(4)).The physician reports thrombotic material on the explanted valve that was reported to have obstructed leaflet function.Of note, the patient has another mechanical mitral valve with no thrombotic issues and will continue to be monitored for any non-diagnosed thrombophilia problems.The physician suggests that coagulation alterations in combination with the small size of the valve caused the thrombotic material formation.The patient is reported to be discharged.

Event Description

On (b)(6) 2007, a 19mm regent valve was implanted in the aortic position.In (b)(6) 2018, high gradient and stenosis were observed and on (b)(6) 2018, the patient was admitted to the hospital for heart failure.On (b)(6) 2018, a valve replacement surgery was performed and the valve was exchanged for another 19mm regent valve (serial number: (b)(6)).The physician reports thrombotic material on the explanted valve that was reported to have obstructed leaflet function.Of note, the patient has another mechanical mitral valve (serial number: (b)(6)) with no thrombotic issues and will continue to be monitored for any non-diagnosed thrombophilia problems.The physician suggests that coagulation alterations in combination with the small size of the valve caused the thrombotic material formation.The patient is reported to be discharged.

Manufacturer Narrative

Explant was reported due to high gradient, stenosis, and heart failure.The thrombotic material seen at explant was confirmed.There was thrombotic material in the pivot recesses, which limited the mobility of the leaflets.No acute inflammation was 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 thrombosis could not be conclusively determined; however, per the site the physician suggested that "coagulation alterations in combination with the small size of the valve caused the thrombotic material formation.".

• 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: 8699659
• MDR Text Key: 148014672
• Report Number: 2648612-2019-00043
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2012
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: 0002097506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention