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

Device Problem Leak/Splash (1354)

Patient Problems Aortic Insufficiency (1715); Ventricular Fibrillation (2130)

Event Type  Injury  

Manufacturer Narrative

Gtin number: 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

The following event was obtained from a literature abstract titled, "an open stuck valve highly suspected of involvement with severe treatment-resistant ventricular fibrillation (vf) after taking off the cardiopulmonary bypass (cpb)." eleven years ago, the patient was diagnosed with aortic regurgitation due to infectious endocarditis.No surgical treatment performed then since the patient was asymptomatic.On an unknown date, due to the tendency for left ventricle enlargement and mitral regurgitation, the patient underwent mitral annuloplasty and aortic valve replacement (avr).During the mitral annuloplasty, a 30 mm edwards physio ring was implanted and this 23 mm sjm mechanical valve was selected for the avr.Since the interventricular septal muscle was thickened, structural obstruction was a concern.The valve's hinges were rotated 90 degrees from the physician's usual implant style.After the valve was sutured, aortic cross clamping was released.Ventricular fibrillation occurred.Lidocaine, amiodarone and magnesium sulfate was administered and direct-current defibrillator was tried 22 times but defibrillation was unsuccessful.Tee showed a collapsed ventricle and continuous blood flow (1.5l/min) was observed and an open stuck valve leaflet was suspected.The aortic root was re-opened and the sjm mechanical valve's leaflets were found to be stuck in the open position.The valve¿s hinge was changed and re-sutured on the ¿usual¿ position.Vf was not present and the patient came off cpb without problem.

• Brand Name: SJM MECHANICAL HEART VALVE (UNKNOWN)
• 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: 5233601
• MDR Text Key: 31530352
• Report Number: 2648612-2015-00035
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR