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

Model Number 25AGN-751

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombus (2101)

Event Date 09/07/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, a 25mm regent valve was implanted secondary to infectious endocarditis of the bicuspid aortic valve.Post-implant, a thrombus was noted on the leaflet of the valve and could not be removed easily with a saline flush or a gauze swab resulting in an increased bypass/cross clamp time.The 25mm valve was explanted and replaced with a 23mm regent valve.

Manufacturer Narrative

An event of "a thrombus on the leaflet of the valve" was reported.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.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

The reported event of "a thrombus on the leaflet of the valve" could not be confirmed.No tissue or coagulated blood was noted on the valve orifice or leaflets, nor within the solution that contained the valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

Event Description

On (b)(6) 2017, a 25mm regent valve was implanted secondary to infectious endocarditis of the bicuspid aortic valve.Post-implant, a thrombus was noted on the leaflet of the valve which was unable to be removed with saline flush or gauze swab.The 25mm valve was explanted and replaced with a 23mm regent valve.There was an increase in bypass and crossclamp time due to the removal and implantation of the valve, as well as efforts to remove the thrombus.

• Brand Name: SJM REGENT HEART VALVE
• 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6954175
• MDR Text Key: 89468254
• Report Number: 2648612-2017-00088
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2022
• Device Model Number: 25AGN-751
• Device Catalogue Number: 25AGN-751
• Device Lot Number: 6025641
• Other Device ID Number: 05414734006279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR