MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. REGENT AORTIC MHV,FLEX C UFF,19MM; HEART-VALVE, MECHANICAL

Model Number 19AGFN-756

Device Problems Crack (1135); Noise, Audible (3273)

Patient Problem Death (1802)

Event Date 08/25/2014

Event Type  Death  

Manufacturer Narrative

The results of this investigation concluded a fracture went through the entire thickness of the orifice at the blend radius section.Both leaflets were fully mobile and no damage was found to the recessed pivot areas, or leaflets.There was no evidence of material defect in the carbon coating that may have caused or contributed to the orifice damage.Rather, the orifice damage was apparently caused by some external force applied to the orifice which overstressed the carbon material.There was no evidence found to suggest there was an intrinsic defect in the valve, as supported by the review of the device history record and the analysis performed.The cause of the reported event remains unknown.

Event Description

The patient underwent double valve replacement and an aortic annular enlargement.After implanting the mitral valve, this 19mm sjm regent valve was implanted in the aortic position.While attempting to rotate the valve, an audible "pop" was heard and a crack was observed on the valve orifice near the pivot guard.The valve was removed and replaced with another 19mm sjm regent valve.The patient expired due to lv failure on an unknown date.According to the physician, the patient was unstable for multiple reasons after undergoing surgery.

Manufacturer Narrative

(b)(4).

• Brand Name: REGENT AORTIC MHV,FLEX C UFF,19MM
• 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 0072 5
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 0072 5
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4226650
• MDR Text Key: 12787301
• Report Number: 2648612-2014-00049
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2018
• Device Model Number: 19AGFN-756
• Device Lot Number: 4105951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2013
• 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): Death; Hospitalization
• Patient Age: 40 YR