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 Problems Gradient Increase (1270); Insufficient Information (3190)

Patient Problems Thrombus (2101); Stenosis (2263)

Event Date 01/01/2011

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On an unknown date in 2008 a 19mm regent heart valve was implanted.On (b)(6) 2011 the valve was explanted due to mechanical aortic valve stenosis.Patient status is unknown.No more additional will be provided.

Event Description

On (b)(6) 2008, a 19mm regent heart valve was implanted.During a follow-up, a echo was performed a frozen leaflet, elevated gradient with resultant stenosis was noted.On 13 october 2011, the regent valve was explanted and exchanged for a 19mm carpentier edwards valve.During explant procedure, there were two areas on either side of the leaflet at the pivot points which had thrombus.Patient status is unknown.No more additional will be provided.Manufacturer report number: 2648612-2011-00078.

Manufacturer Narrative

Correction: please retract this report 2648612-2019-00057, the same issue was previously reported as 2648612-2011-00078.

• 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: 8832055
• MDR Text Key: 152363150
• Report Number: 2648612-2019-00057
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2013
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: 0002096722
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR