MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, B.V. (CD) SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number 25AGFN-756

Device Problems Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Thrombosis/Thrombus (4440); Valvular Insufficiency/ Regurgitation (4449)

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2021, a patient had undergone an implant procedure of a 25mm regent.On (b)(6) 2021, the patient was brought back for an emergent redo avr procedure.One of the leaflets of the regent valve was not pivoting properly, this caused a large jet to come through, and one leafet appeared to not open.The leaflet appeared to have thrombosis on it.Dr.(b)(6) replaced this valve with an edwards magna ease.

Manufacturer Narrative

An event of the one of the leaflets of the regent valve not pivoting properly was reported.Morphological and hydrodynamic examination indicated the valve met abbott specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Hydrodynamic testing upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.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, B.V. (CD); lot 21; caguas west industrial park; caguas, puerto rico 00726 -099
• MDR Report Key: 11507903
• MDR Text Key: 240444910
• Report Number: 3003681312-2021-00003
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006262
• UDI-Public: 05414734006262
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25AGFN-756
• Device Catalogue Number: 25AGFN-756
• Device Lot Number: 7311449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 47 YR