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

Model Number CVD0045

Device Problem Gradient Increase (1270)

Patient Problems Aortic Regurgitation (1716); Arrhythmia (1721); Cardiac Arrest (1762); Death (1802); Unspecified Infection (1930); Mitral Regurgitation (1964); Heart Failure (2206); Complaint, Ill-Defined (2331); Aortic Dissection (2491); Low Cardiac Output (2501); Multiple Organ Failure (3261)

Event Type  Injury  

Manufacturer Narrative

The gtin and manufacturer could not be verified as the lot and serial numbers are unknown.The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

According to the journal article "hemodynamics of 17-mm vs.19-mm st.Jude medical regent and annulus enlargement" (doi: 10.1177/0218492315581574), 20 patients were implanted with a 17mm regent mechanical heart valve and 35 patients were implanted with a 19mm regent valve.The objective was to compare early and mid-term clinical and hemodynamic outcomes of 17mm versus 19mm regent valves with concomitant aortic annulus enlargement.There were a total of five deaths and general reports that included but were not limited to patient-prosthesis mismatch, high gradients, arrhythmias, low cardiac output, permanent ventricular pacing, mitral and/or aortic regurgitation, aortic dissection with reoperation and infectious complications.The causes of death were: low cardiac output, cardiac arrest, bleeding, multiorgan failure and heart failure.No specific devices or patients were identifiable.

• Brand Name: REGENT MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC. (CS); p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. (CS); 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: 5093598
• MDR Text Key: 26369733
• Report Number: 3001743903-2015-00036
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: CVD0045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention