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

Model Number 23AGN-751

Device Problem Obstruction of Flow (2423)

Patient Problem Aortic Dissection (2491)

Event Date 09/08/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, a 23mm regent valve was implanted in the aortic position in a patient who had undergone aortic valve reconstruction and replacement of an aneurysmal ascending aorta six months prior to implant of the regent valve.Following the prior reconstruction, aortic insufficiency resulted which led to the need for the regent valve.When the valve was tested using the leaflet tester, the leaflets did not open.The valve was then explanted, new sutures were placed and the original valve was re-implanted.The sutures were not tied down and the valve was tested, however the leaflets still did not open and the valve was explanted.Per report, the aortic wall was injured by the maneuvers.A 23mm masters conduit valve was implanted.

Manufacturer Narrative

The reported event of "the leaflets could not be opened" could not be confirmed.Gross morphological and functional examination confirmed no anomalies were found with 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.

• 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: 6903429
• MDR Text Key: 87734589
• Report Number: 2648612-2017-00080
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2021
• Device Model Number: 23AGN-751
• Device Catalogue Number: 23AGN-751
• Device Lot Number: 5437585
• Other Device ID Number: 05414734006101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2016
• 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): Required Intervention