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

Model Number 23AGN-751

Device Problem Degraded (1153)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

In 2009, a 23mm regent heart valve was implanted in the aortic position.On (b)(6) 2016, a double valve replacement procedure was performed and the regent valve was explanted as it was reported one of the leaflets was immobile and in the open position in situ.A reason for the immobile leaflet was not found and details regarding the second valve that was explanted are unknown.Ex vivo, the regent valve's leaflets were mobile.A 23mm trifecta valve was implanted.

Manufacturer Narrative

The results of this investigation concluded there was fibrous pannus ingrowth on the inflow surface with microcalcifications, which resulted in the narrowing of the inflow diameter.The leaflets were able to close and open completely and easily.No inflammation was present on the valve.A review of the device history record showed the device met specifications prior to leaving sjm manufacturing facilities.There was no evidence found to suggest the cause of the fibrin, pannus or calcifications were due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the reported event remains unknown.

Event Description

In 2009, a 23mm regent heart valve was implanted in the aortic position.On (b)(6) 2016, the regent valve was explanted as it was reported one of the leaflets was immobile and in the open position in situ.A reason for the immobile leaflet was not found although the physician suspected it may have been due to the position of the mitral valve.Ex vivo, the regent valve's leaflets were mobile.A 23mm trifecta valve was implanted.Concomitantly, the native mitral valve was replaced with a prosthetic valve.

• 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: 5697644
• MDR Text Key: 46503746
• Report Number: 2648612-2016-00052
• 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: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/07/2014
• Device Model Number: 23AGN-751
• Device Catalogue Number: 23AGN-751
• Device Lot Number: 2968758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2009
• 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
• Patient Age: 70 YR