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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, a 19mm regent valve was selected for implant.While implanting the device, the physician observed a leaflet that was not coapting properly and appeared to be stuck.The physician explanted the valve and implanted a 17mm regent valve in the smaller annulus.No patient consequences were reported.

Event Description

On (b)(6) 2019, a 19mm regent valve was selected for implant.While implanting the device, the physician observed a leaflet that was not coapting properly and appeared to be stuck.The physician explanted the valve and implanted a 17mm regent valve in the smaller annulus.No patient consequences were reported.

Manufacturer Narrative

The reported event of an obstructed leaflet could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.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.Based on the information received, the cause of the reported incident could not be conclusively determined; however, information from the field indicated that a smaller, 17mm, regent valve was used to complete the procedure, which is possible evidence of initial over-sizing.Please note, per the instructions for use artmt100122074, rev a, "proper valve size selection is crucial.Do not oversize the valve.If the native annulus measurement falls between two sjm regent¿ mechanical heart valve sizes, use the smaller size sjm regent¿ mechanical heart valve.".

• 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: 8641348
• MDR Text Key: 146094466
• Report Number: 2648612-2019-00037
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2023
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: 6622592
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention